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Bioequivalence of 240  mg Apalutamide Tablets and Preparation in Aqueous Food Vehicles for Alternative Administration
AbstractA 240-mg single tablet has been developed with the focus of reducing the pill burden of the apalutamide daily dose of 240  mg (4 × 60-mg tablets). An open-label, randomized, single-dose phase 1 study with a 2-sequence and 2-period crossover design in healthy men determined the bioequivalence of a 240-mg single tablet versus the currently available 4 × 60-mg tablets (Part 1, N = 74) and assessed effect of a high- fat meal (Part 2, N = 21) on apalutamide maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve (AUC0-72  h). The 90% confidence interval of geometric mean ratios...
Source: Clinical Pharmacology in Drug Development - November 21, 2023 Category: Drugs & Pharmacology Authors: Alex Yu, Mieke Van Uffel, Juhui J. Jiao, Rosamerlinda Rosales, Maura Erba, Nahor Haddish ‐Berhane Tags: Original Article Source Type: research

Bioequivalence and Pharmacokinetics Study of Two Zidovudine/Lamivudine Tablets in Chinese Healthy Volunteers
The objective of this study was to investigate the bioequivalence and pharmacokinetics (PKs) of test and reference preparations of zidovudine/lamivudine tablets in healthy Chinese subjects. We designed a randomized, open, single-center, single-dose, 2-crossover experiment with a 7-day washout period involving 20 healthy subjects. The subjects were given a single dose of the test or reference preparation after fasting overnight for 10  hours. Blood samples were subsequently collected at scheduled time points from 0 hour (preadministration) up to 24 hours postadministration. The plasma concentrations of zidovudine and lam...
Source: Clinical Pharmacology in Drug Development - November 21, 2023 Category: Drugs & Pharmacology Authors: Xiaomei Huang, Gongzhu Wang, Jian Huang, Wu Liang, Huiyu Guan, Haisha Liu, Yuan Deng, Yu You, Bikui Zhang Tags: Original Article Source Type: research

Bioequivalence of 200  mg Amisulpride Tablets in Healthy Chinese Volunteers under Fasting and Fed Conditions
This study demonstrated that generic and reference products of amisulpride tablets were bioequivalent in healthy Chinese volunteers under fasting and fed conditions. (Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - November 21, 2023 Category: Drugs & Pharmacology Authors: Yi Cao, Jianfen Su Tags: Original Article Source Type: research

Effect of the Phosphate Binder Sevelamer Carbonate on the Bioavailability of Enarodustat, an Oral Erythropoiesis Stimulating Agent
AbstractEnarodustat is an orally available hypoxia-inducible factor-prolyl hydroxylase inhibitor which can correct the erythropoietic capacity and improve anemia in chronic kidney disease. Sevelamer carbonate, a non-calcium-based polymeric resin, is one of the commonly prescribed agents for the management of hyperphosphatemia in patients undergoing hemodialysis. This was an open-label, crossover study in healthy male subjects (N  = 12) that evaluated the effect of sevelamer carbonate (2400 mg) on the bioavailability of enarodustat (25 mg) when the 2 drugs were administered together (Treatment B) or when enarodustat was...
Source: Clinical Pharmacology in Drug Development - November 18, 2023 Category: Drugs & Pharmacology Authors: Sudhakar M. Pai, Hiroyuki Yamada Tags: Original Article Source Type: research

Bioequivalence Study of Epalrestat for Healthy Chinese Subjects
This study was designed to evaluate the bioequivalence in healthy Chinese subjects of a new test formulation and reference formulation of oral epalrestat (50 mg) in the fasting state. The study was performed with 44 healthy Chinese subjects accor ding to a randomized 2-way crossover design. The main pharmacokinetic parameters of test formulation and reference formulation as follows: 4793 and 4781 ng/mL for maximum plasma concentration, 8556 and 8431 ng h/mL for area under the plasma concentration-time curve extrapolated to infinity. The tes t formulation of epalrestat was bioequivalent to the reference formulation. The b...
Source: Clinical Pharmacology in Drug Development - November 17, 2023 Category: Drugs & Pharmacology Authors: Dandan Yang, Xiaodan Wang, Yi Duan, Yichao Xu, Zourong Ruan, Bo Jiang, Honggang Lou, Jinliang Chen Tags: Original Article Source Type: research

Support for Removing Pharmacodynamic and Clinical Efficacy Testing of Biosimilars: A Critical Analysis
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - November 15, 2023 Category: Drugs & Pharmacology Authors: Sarfaraz K. Niazi Tags: Commentary Source Type: research

The Effect of BI 730357 (Retinoic Acid ‐Related Orphan Receptor Gamma t Antagonist, Bevurogant) on the Pharmacokinetics of a Transporter Probe Cocktail, Including Digoxin, Furosemide, Metformin, and Rosuvastatin: An Open‐Label, Non‐randomized, 2‐Period Fixed‐Sequence Trial in Healthy Subjects
AbstractEvaluating Drug-Drug Interactions (DDIs) for new investigational compounds requires several trials evaluating different drugs with different transporter specificities. By using a cocktail of drugs with different transporter specificities, a single trial could evaluate the pharmacokinetics (PKs) of each cocktail drug simultaneously, reducing the number of clinical DDI trials required for clinical development. We aimed to investigate the effect of steady-state Boehringer Ingelheim (BI) 730357 (bevurogant) on the PKs of a validated and optimized 4-component transporter cocktail. This open-label, non-randomized, 2-peri...
Source: Clinical Pharmacology in Drug Development - November 14, 2023 Category: Drugs & Pharmacology Authors: HeeJae Choi, Fenglei Huang, Mary Flack Tags: Original Article Source Type: research

Population Pharmacokinetics of Tenofovir Alafenamide Fumarate and Its Metabolite Tenofovir in Healthy Chinese Volunteers
This study aimed to establish the prodrug –metabolite population pharmacokinetic (PK) model for TAF and its metabolite tenofovir (TFV) in healthy Chinese volunteers and evaluate the factors affecting the PK. Using 1043 TAF and 1198 TFV plasma sample concentrations collected from 67 healthy volunteers, a population PK model was developed u sing the nonlinear mixed-effects model. The 1-compartment model containing 4 transit compartments and the 2-compartment model accurately described the PK of TAF and TFV, respectively. Covariates such as meal state and sex were found to be statistically significant and potentially clinic...
Source: Clinical Pharmacology in Drug Development - November 13, 2023 Category: Drugs & Pharmacology Authors: Xingfang Ji, Yunfei Li, Zhipeng Wang, Yuan Gao, Ling Wang Tags: Original Article Source Type: research