Clinical Pharmacology in Drug Development

Article	Citations
Pharmacokinetic and Bioequivalence Study of Eldecalcitol Soft Capsules in Healthy Chinese Subjects	38
Issue Information	30
Bioequivalence of Recombinant Human Teriparatide Injection in Healthy Adult Female Subjects in the Fasting State	23
Safety and Pharmacokinetics of Single‐Dose Mirikizumab in Chinese Healthy Participants: Results From a Phase 1 Study	22
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Muscarinic M3 Receptor‐Positive Allosteric Modulator ASP8302 Following Single and Multiple Ascending Oral Doses in Healthy	18
Apixaban Single‐Dose Pharmacokinetics, Bioavailability, Renal Clearance, and Pharmacodynamics Following Intravenous and Oral Administration	17
Pharmacokinetics and Pharmacodynamics of Lansoprazole/Sodium Bicarbonate Immediate‐release Capsules in Healthy Chinese Subjects: An Open, Randomized, Controlled, Crossover, Single‐, and Multiple‐dose	16
Pharmacokinetic/Pharmacodynamic Evaluation of Ivosidenib or Enasidenib Combined With Intensive Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed IDH1/2‐Mutant Acute Myel	15
Bioequivalence Study of Two Formulations of Mifepristone Tablets in Healthy Chinese Subjects Under Fasting Conditions	15
Pharmacokinetics, Bioequivalence, and Safety Evaluation of 2 Formulations of 10‐mg Rivaroxaban Tablets: A 4‐Period Crossover Trial	15
Pharmacokinetics and Safety of Linezolid Tablets of 2 Different Manufacturers in Healthy Chinese Subjects in Fasting and Fed States	14
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Issue Information	13
Issue Information	13
Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients	13
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Effect of Paricalcitol Combined with Cinacalcet on Calcium and Phosphorus Metabolism in Patients Receiving Maintenance Hemodialysis	12
Bioequivalence and Pharmacokinetic Profiles of 2 Trimetazidine Modified‐release Tablets Under Fasting and Fed Conditions in Chinese Healthy Subjects	12
A Single‐center, Open‐label, Parallel Control Study Comparing the Pharmacokinetics and Safety of a Single Oral Dose of Roflumilast and Its Active Metabolite Roflumilast N‐oxide in Healthy Chinese and	12
Pharmacokinetics, Bioequivalence, and Safety of 2 Formulations of Hydroxychloroquine Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions	11
Issue Information	11
Pharmacokinetics of Icosapent Ethyl: An Open‐Label, Multiple Oral Dose, Parallel Design Study in Healthy Chinese Subjects	11
2022 CPDD Reviewers	11
Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?	10
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Comparison of Two Manufacturing Processes of Daprodustat for Bioequivalence and Dissolution in Healthy Volunteers: A Randomized Crossover Study	10
Lack of an Effect of Supratherapeutic Dose of Venlafaxine on Cardiac Repolarization in Healthy Subjects	10
A Bioequivalence Study of Avanafil in Healthy Chinese Male Subjects Under Fasting and Fed Conditions: Results of a Randomized, Open‐Label, Single‐Dose, 2‐Sequence, 2‐Period Crossover Study	10
Bioequivalence of a Pediatric Fixed‐Dose Combination Tablet Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Compared With Coadministration of the Separate Agents in Healthy Adults: An Open‐La	9
Pharmacokinetic and Bioequivalence Evaluation of Single‐Tablet and Separate‐Tablet Regimens for Ainuovirine, Lamivudine, and Tenofovir Disoproxil Fumarate in Chinese Healthy Subjects	9
Blood Pressure Recovery After Dobutamine Antagonism: Partial With Landiolol, None With Esmolol	9
Pharmacokinetic and Pharmacologic Characterization of the Dihydrotetrabenazine Isomers of Deutetrabenazine and Valbenazine	9
A Phase 1 First‐in‐Human Single‐Ascending‐Dose Trial With ESB1609, a Selective Agonist to the Sphingosine‐1‐Phosphate Receptor 5	8
Effect of Dietary Intake on the Pharmacokinetics of the Multitargeted Receptor Tyrosine Kinase Inhibitor Famitinib: Results From a Phase 1 Study in Healthy Chinese Participants	8
Issue Information	8
Bioequivalence and Pharmacokinetic Study of 2 Edoxaban Tablets in Healthy Chinese Subjects	8
Issue Information	8
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects	8
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Issue Information	8
Comparative Pharmacokinetic Profiles of a Novel Low‐Dose Micronized Formulation of Raloxifene 45 mg (AD‐101) and the Conventional Raloxifene 60 mg in Healthy Subjects	8
Pharmacokinetics, Safety, and Bioequivalence of 2 Lopinavir/Ritonavir (200/50 mg) Tablets in Healthy Chinese Volunteers: Effect of Food on Absorption	8
In Memoriam: Hartmut Derendorf (1953–2020)	8
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Pharmacokinetics, Safety, and Tolerability of a Single Oral Dose of Abacavir/Dolutegravir/Lamivudine Combination Tablets in Healthy Japanese Study Participants	8
Effect of Food on the Pharmacokinetics and Pharmacodynamics of a Single Oral Dose of SHR4640, a Selective Urate Transporter 1 Inhibitor, in Healthy Chinese Male Volunteers	8
A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability After Subcutaneous Administration of Toz	7
GLPG1205, a GPR84 Modulator: Safety, Pharmacokinetics, and Pharmacodynamics in Healthy Subjects	7
Drug‐Drug Interactions With the Hepatitis B Virus Capsid Assembly Modulator JNJ‐56136379 (Bersacapavir)	7
Pharmacokinetics and Bioequivalence of the Lubiprostone Capsule in Healthy Chinese Subjects	7
Biosimilarity Assessment of the Biosimilar Teriparatide Candidate and the Reference Drug in Healthy Subjects	7
Pharmacokinetics and Bioequivalence of a Generic and a Branded Budesonide Nasal Spray in Healthy Chinese Subjects	7
Bioequivalence of 2 Aripiprazole Orally Disintegrating Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions	7
Issue Information	7
Changes in Urinary Uric Acid Concentration after Dotinurad Administration to Patients with Hyperuricemia: A Post Hoc Analysis of Two Clinical Trials in Japan	7
Bioequivalence Study of Ezetimibe Tablets After a Single Oral Dose of 10 mg in Healthy Japanese Subjects Under Fasting Conditions	7
A Bioequivalence Trial of Dienogest in Healthy Chinese Participants Under Fed Conditions	7
Randomized Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2831781 in Healthy Japanese and White Participants	6
Pharmacokinetics of Nitazoxanide Dry Suspensions After Single Oral Doses in Healthy Subjects: Food Effects Evaluation and Bioequivalence Study	6
PKPD Modeling and Simulations to Support Biosimilar Development of Biphasic Insulin Aspart 30	6
Pilocarpine‐Induced Effects on Salivary Secretion as a Pharmacological Biomarker for Cholinergic Parasympathetic Activation	6
Exposure‐Response Analysis to Assess the Concentration‐QTc Relationship of Iberdomide	6
Nlmixr2 Versus NONMEM: An Evaluation of Maximum A Posteriori Bayesian Estimates Following External Evaluation of Gentamicin and Tobramycin Population Pharmacokinetic Models	6
A Pharmacokinetic Bioequivalence Study Comparing Different‐Strength and ‐Size Capsules of Isavuconazonium Sulfate in Healthy Japanese Subjects	6
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Bioequivalence and Safety Assessment of 2 Formulations of Low‐Dose Metformin Hydrochloride under Fasting Conditions in Healthy Chinese Participants: A Randomized Phase 1 Clinical Trial	6
Evaluation of Drug–Drug Interaction Potential of Enarodustat (JTZ‐951) Using a Cytochrome P450 Probe Cocktail	6
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Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor	6
Issue Information	5
Pharmacokinetics and Safety of Atogepant Co‐administered with Quinidine Gluconate in Healthy Participants: A Phase 1, Open‐Label, Drug‐Drug Interaction Study	5
Comparative Bioequivalence and Food Effect of Two Formulations of 30‐mg Nifedipine Controlled‐Release Tablets in Healthy Chinese Adults	5
Intravenous Perampanel as an Interchangeable Alternative to Oral Perampanel: A Randomized, Crossover, Phase I Pharmacokinetic and Safety Study	5
Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI‐751): Results From a Randomized Phase 1 Trial	5

A Phase 1, Randomized, Double‐Blind, Placebo‐Controlled, Single Ascending Dose Trial of AWZ1066S, an Anti‐Wolbachia Candidate Macrofilaricide	5
Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75‐mg Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo‐Controlled Trial	5
Safety, Tolerability, and Pharmacokinetics of Anaprazole, a Novel Proton Pump Inhibitor, in Healthy Chinese Subjects	5
Bioequivalence Assessment of Two Dapoxetine Hydrochloride Formulations in Healthy Chinese Males Under Fasted and Fed Conditions	5
A Model‐Informed Drug Development Approach to Design a Phase 3 Trial of Teverelix Drug Product in Advanced Prostate Cancer Patients with Increased Cardiovascular Risk	5
A Comparative Analysis of the Pharmacodynamic and Pharmacokinetic Properties of 2 Controlled‐Release Formulations Versus a Marketed Orlistat Product	5
Concentration–QTc Relationship from a Single Ascending Dose Study of ANAVEX3‐71, a Novel Sigma‐1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotempor	5
A Drug‐Drug Interaction Study to Evaluate the Impact of Rimegepant on OCT2‐ and MATE1‐Mediated Transport of Metformin in Healthy Participants	5
A Reference‐Scaled Average Bioequivalence Study of Azithromycin Tablets Manufactured in China and the United States: An Open‐Label, Randomized, Single‐Dose, 3‐Way Crossover Study in Healthy Chinese Su	5
Single‐Dose Pharmacokinetics and Safety of Ubrogepant in Adults With Hepatic Impairment: Results From an Open‐Label, Phase 1 Trial	5
Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF‐07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS‐CoV‐2, in Healthy Adult Participants	5
Bioequivalence of Esaxerenone Conventional Tablet and Orally Disintegrating Tablet: Two Single‐Dose Crossover Studies in Healthy Japanese Men	5
Effects of Tablet Formulation, Food, or Gastric pH on the Bioavailability of Asundexian	5
Bioequivalence Study of Bedaquiline Fumarate Tablets in Healthy Chinese Subjects	4
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ZY‐IL1 in Three Patients with Cryopyrin‐Associated Periodic Syndromes	4
Pharmacokinetic and Safety Comparison of Fixed‐Dose Combination of Cilostazol/Rosuvastatin (200 + 20 mg) Versus Concurrent Administration of the Separate Components in Healthy Adults	4
Safety, Pharmacokinetics, Pharmacodynamics, and Formulation of Liver‐Distributed Farnesoid X‐Receptor Agonist TERN‐101 in Healthy Volunteers	4
Pharmacokinetics and Pharmacodynamics of Etripamil, an Intranasally Administered, Fast‐Acting, Nondihydropyridine Calcium Channel Blocker	4
Target‐Mediated Modeling of Alirocumab in Adolescents and Children ≥8 to <12 Years of Age Using Phase II and III Data	4
Phase 1 Clinical Results for NP10679, a pH‐sensitive GluN2B‐selective N‐methyl‐d‐aspartate Receptor Inhibitor	4
Effect of Pevonedistat, an Investigational NEDD8‐Activating Enzyme Inhibitor, on the QTc Interval in Patients With Advanced Solid Tumors	4
Pharmacokinetics and Bioequivalence Evaluation of 2 Olmesartan Medoxomil and Amlodipine Besylate Fixed‐Dose Combination Tablets in Healthy Chinese Volunteers Under Fasting and Fed Conditions	4
Issue Information	4
Issue Information	4
Phase 1, Single‐ and Multiple‐Ascending‐Dose, Food‐Effect, and East Asian Subject Studies to Assess the Pharmacokinetics, Safety, and Tolerability of Bempedoic Acid, a Selective Inhibitor of Adenosine	4
2023 CPDD Abstract Booklet	4
Effect of Colonic Absorption on the Pharmacokinetic Properties of Delayed‐Release and Extended‐Release Methylphenidate: In Vivo, In Vitro, and Modeling Evaluations	4
Evaluation of a Low‐Fat Low‐Calorie Meal on the Relative Bioavailability of Trametinib and Dabrafenib: Results From a Randomized, Open‐Label, 2‐Part Study in Healthy Participants	4
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Safety, Tolerability, and Pharmacokinetics of Voriconazole for Injection in Two Preparations in Chinese Healthy Adult Volunteers	4
Phase 1 Study Evaluating the Effects of the Proton Pump Inhibitor Rabeprazole and Food on the Pharmacokinetics of Lorlatinib in Healthy Participants	4
Pharmacokinetic Properties of an FDA‐approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose	4
Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination	4
Pharmacokinetics of Single and Multiple Oral Administration of a Self‐emulsifying Formulation of Highly Purified Eicosapentaenoic Acid Ethyl Ester (MND‐2119) Compared With the Nonself‐emulsifying Form	4
Pharmacokinetics, Safety, and Tolerability of Brivaracetam in Healthy Elderly Participants	4
Evaluation of Food Effect on the Pharmacokinetics of Velufenacin, a New Muscarinic Receptor Antagonist, in Healthy Subjects	4
Can Intranasal Nalmefene Reduce the Number of Opioid Overdose Deaths?	4
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An Open‐Label, Randomized, 2‐Way, Crossover Bioequivalence Study of Cefradine Capsules in Healthy Chinese Volunteers	4
Pharmacokinetics and Bioequivalence of Vardenafil Hydrochloride in Healthy Chinese Volunteers	4
Effect of Phosphate Binders and a Dietary Iron Supplement on the Pharmacokinetics of a Single Dose of Vadadustat in Healthy Adults	4
Phase 1, Single‐Center, Double‐Blind, Randomized, Placebo‐Controlled Studies of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of the Sirtuin 6 Activator SP	4
Pharmacokinetics and Pharmacodynamics of Burixafor Hydrobromide (GPC‐100), a Novel C‐X‐C Chemokine Receptor 4 Antagonist and Mobilizer of Hematopoietic Stem/Progenitor Cells, in Mice and Healthy Subje	4
Comparative Bioavailability of a Single Dose of Trametinib (TMT212) Containing 9% vs 11% Dimethyl Sulfoxide in Randomized Healthy Volunteers to Assess Long‐Term Storage at Room Temperature	4
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Oral NLRP3 Inflammasome Inhibitor ZYIL1: First‐in‐Human Phase 1 Studies (Single Ascending Dose and Multiple Ascending Dose)	4
Population Pharmacokinetic Model of N‐Acetylcysteine During Periods of Recurrent Hypoglycemia in Healthy Volunteers	4
Evaluation of Potential Food Effects and Drug Interactions With Lansoprazole in Healthy Adult Volunteers Receiving Futibatinib	4
Comparability of Elezanumab Safety, Tolerability, and Pharmacokinetics in Healthy Japanese, Chinese, and White Participants	4
Pharmacokinetic Interaction Between the MEK1/MEK2 Inhibitor Trametinib and Oral Contraceptives Containing Norethindrone and Ethinyl Estradiol in Female Patients With Solid Tumors	4
Effect of Carbamazepine on the Pharmacokinetics of Erdafitinib in Healthy Participants	4
Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study	3
Pharmacokinetic and Bioequivalence Studies of 2 Metformin Glibenclamide Tablets in Healthy Chinese Subjects Under Fasting and Fed Conditions	3
ACCP Abstract Booklet	3
Pharmacological Parameters and Pharmacokinetic Variability Derived from Bioequivalence Trials in a Mexican Population	3
Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers	3
Safety, Tolerability, and Pharmacokinetics of Single‐ and Multiple‐Ascending Doses of Sunobinop in Healthy Participants	3
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Scp776, A Novel IGF‐1 Fusion Protein for Acute Therapy to Promote Escape From Apoptosis in Tissues Affected by Ischemic Injury: 2 Randomized Placebo‐Controlled Phase 1 Studies in Healthy Adults	3
Pharmacokinetics and Bioequivalence of Fudosteine in Healthy Chinese Volunteers Under Fasting and Fed Conditions: A 4‐Way Replicate Crossover Study	3
Absolute and Relative Bioavailability of Oral Solid Dosage Formulations of Deucravacitinib in Humans	3
A Phase 1, Open‐Label Study to Evaluate the Effect of Food and Concomitant Itraconazole Administration on the Pharmacokinetics of AMG 986 in Healthy Subjects	3
Evaluation of Proton Pump Inhibitor Esomeprazole on Crizotinib Pharmacokinetics in Healthy Participants	3
Bioequivalence of Blonanserin Tablets Under Fasting and Fed Conditions in Healthy Chinese Subjects	3
Issue Information	3
A Randomized Thorough QT Study of Apomorphine Sublingual Film in Patients With Parkinson's Disease	3
Phase 1 Evaluation of the Bioequivalence and Drug‐Drug Interaction Potential of a Novel Fixed‐Dose Combination of Ezetimibe, Atorvastatin, and Amlodipine	3
Tramadol/Diclofenac Fixed‐Dose Combination for Acute Pain Management: Bioavailability Assessment of a Generic Product	3
Pharmacokinetic Drug‐Drug Interaction Study of Omecamtiv Mecarbil With Amiodarone and Digoxin in Healthy Subjects	3
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Effect of the Phosphate Binder Sevelamer Carbonate on the Bioavailability of Enarodustat, an Oral Erythropoiesis Stimulating Agent	3
A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single‐Dose, Phase 1 Crossover Trial	3
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Phase 1 Maximal Use Pharmacokinetic Study of Tirbanibulin Ointment 1% in Subjects With Actinic Keratosis	3
Issue Information	3
Pharmacokinetics and Bioequivalence of a Generic Ticagrelor 90‐mg Formulation Versus the Innovator Product in Healthy White Subjects Under Fasting Conditions	3
Issue Information	3
An Open‐Label Study to Evaluate the Effect of Eluxadoline on the Single‐Dose Pharmacokinetics of Midazolam in Healthy Participants	3
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Bioequivalence Evaluation Between Acarbose and Metformin Fixed‐Dose Combination and Corresponding Individual Components in Healthy Chinese Male and Female Subjects	3

Effect of Food, Crushing of Tablets, and Antacid Coadministration on Maribavir Pharmacokinetics in Healthy Adult Participants: Results From 2 Phase 1, Open‐Label, Randomized, Crossover Studies	3
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A Bioequivalence Trial of Lenvatinib Mesylate Capsules in Healthy Subjects Under Fasting and Postprandial Conditions	3
Effect of Roxadustat on the Pharmacokinetics of Simvastatin, Rosuvastatin, and Atorvastatin in Healthy Subjects: Results From 3 Phase 1, Open‐Label, 1‐Sequence, Crossover Studies	3
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Pharmacokinetics, Tolerability, and Safety of Glecaprevir/Pibrentasvir Co‐formulated Bilayer Tablet Following Repeated Administration in Healthy Chinese Adults	3
Pharmacokinetics and Safety Evaluation of Maribavir in Healthy Japanese and Matched White Participants: A Phase 1, Open‐Label Study	3
Bioequivalence and Food Effect Assessment of 2 Rivaroxaban Formulations in Healthy Chinese Volunteers: An Open, Randomized, Single‐Dose, and 4‐Period Crossover Study	3
Issue Information	3
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Neonatal Fc Receptor Inhibitor Rozanolixizumab: An Ethnic Sensitivity Study in Healthy Japanese, Chinese, and White Participants	3
Pharmacokinetic Comparison of Favipiravir Oral Solution and Tablet Formulations in Healthy Thai Volunteers	3
Four‐Way Crossover Phase 1 Thorough QT Study to Assess Cardiac Safety of Domperidone and Consideration for Design and Conduct of QT/QTc Study in China	3
A Randomized, Single‐dose, Phase I Clinical Comparison of a Trastuzumab Biosimilar With a Reference Trastuzumab Formulation in Healthy Chinese Male Volunteers	3
Bioequivalence of 240 mg Apalutamide Tablets and Preparation in Aqueous Food Vehicles for Alternative Administration	3
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Correction to Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1,Open‐Label, Single‐Dose, Parallel‐Group Study	3
A Single‐dose, Two‐Period Crossover Bioequivalence Study Comparing Two Liraglutide Formulations in Healthy Chinese Subjects	3
Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects	3