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Issue Information
(Source: Clinical Pharmacology in Drug Development)
Source: Clinical Pharmacology in Drug Development - October 3, 2023 Category: Drugs & Pharmacology Tags: Issue Information Source Type: research

Association Study of Esomeprazole Pharmacokinetics and CYP2C19 Gene Polymorphisms
AbstractTo investigate the association between esomeprazole pharmacokinetics andCYP2C19 gene polymorphisms in a cohort of 95 healthy Chinese participants. A cohort of 95 participants was assembled and stratified into 2 distinct groups, receiving either 20 or 40  mg of esomeprazole through oral administration. The subjects encompassed 17 poor metabolizers, 47 intermediate metabolizers, and 31 rapid metabolizers, and their genotypes were ascertained using the polymerase chain reaction–restriction fragment length polymorphism technique. Esomeprazole plasma concentrations were quantified employing a high-performance liquid ...
Source: Clinical Pharmacology in Drug Development - September 30, 2023 Category: Drugs & Pharmacology Authors: Yuan Fang, Xia He, Ai Peng, Yi qi Yang, Jin Xiang Tags: Original Article Source Type: research

Effects of Omeprazole and Verapamil on the Pharmacokinetics, Safety, and Tolerability of Mavacamten: Two Drug –Drug Interaction Studies in Healthy Participants
AbstractTwo open-label, Phase 1 studies assessed the effects of omeprazole (a weak to moderate cytochrome P450 [CYP] 2C19 inhibitor) and verapamil (a moderate CYP3A4 inhibitor) on the pharmacokinetics, safety, and tolerability of mavacamten. In the omeprazole study, healthy participants received mavacamten 15  mg alone or with a 31-day course of omeprazole 20 mg once daily. In the verapamil study, healthy participants received mavacamten 25 mg alone or with a 28-day course of verapamil 240 mg once daily. In the omeprazole study, 27 of 29 randomized participants completed the study. Nine participants receiving mavacamte...
Source: Clinical Pharmacology in Drug Development - September 29, 2023 Category: Drugs & Pharmacology Authors: Vidya Perera, Daniel D. Gretler, Julie D. Seroogy, Manting Chiang, Maria Palmisano, Victoria Florea Tags: Original Article Source Type: research

A Bioequivalence Trial of Dienogest in Healthy Chinese Participants Under Fed Conditions
AbstractThis trial was a randomized, open-label, single-dose, 2-treatment, 2-period, crossover study to evaluate the pharmacokinetic (PK) profile, bioequivalence, and safety of test formulation and reference formulation of 2-mg dienogest tablets in healthy Chinese participants. Eligible participants were randomly administered a single 2-mg dose of either the test formulation or the reference formulation orally under fed conditions, followed by a 1-week washout period and the administration of the other formulation. Samples of blood were collected until 48  hours following administration. The main PK parameters were calcul...
Source: Clinical Pharmacology in Drug Development - September 25, 2023 Category: Drugs & Pharmacology Authors: Chunyan Zhao, Yuxia Wang, Yanhua Shao Tags: Original Article Source Type: research

Bioequivalence of Blonanserin Tablets Under Fasting and Fed Conditions in Healthy Chinese Subjects
AbstractBlonanserin is a novel oral antischizophrenic drug. Under fasting (n = 50) and fed (n = 60) conditions, this study compared the bioequivalence of the generic blonanserin tablet with the reference blonanserin tablet. In this single-center, randomized, open-label, 2-period, 2-sequence, crossover study, 110 patients were randomly given a 4-mg dose of either the test or reference blonanserin tablet with a 14-day washout period. Blood samples were taken before performing and up to 72  hours following. A validated high-performance liquid chromatography-tandem mass spectrometry technique was used to measure the levels of...
Source: Clinical Pharmacology in Drug Development - September 24, 2023 Category: Drugs & Pharmacology Authors: Yuyan Lei, Yu Yan, Junli Lu, Chao Li, Jie Wang, Canxia Li, Lifeng Huang, Caihong Wang, Wanying Liu, Xiaohui Li, Weiming Chen, Man Xia, Lulu Chen Tags: Original Article Source Type: research

Effect of a High ‐Fat Diet on the Pharmacokinetics and Safety of Rivaroxaban in Healthy Chinese Subjects
AbstractThe effects of food on the pharmacokinetics (PKs) and safety of 10-mg rivaroxaban tablets in healthy Chinese subjects were investigated from 1 bioequivalence trial. The bioequivalence trial was designed as randomized, open-label, 2-sequence, 4-period crossover under both fasted and fed conditions. A total of 56 healthy subjects were enrolled, 62.5% were male. These subjects received a single oral 10-mg dose of rivaroxaban with a 7-day washout between 4 periods. Serial PK samples were collected and plasma concentrations were analyzed using validated high-performance liquid chromatography –mass spectrometry. Pharma...
Source: Clinical Pharmacology in Drug Development - September 23, 2023 Category: Drugs & Pharmacology Authors: Xue Sun, Haojing Song, Huan Liu, Bo Qiu, Congyang Ding, Yiting Hu, Wanjun Bai, Zhanjun Dong Tags: Original Article Source Type: research

Bioequivalence of Reference and Biosimilar Preparations of Premixed Biphasic Insulin Aspart: A Comparative Clamp Study
AbstractBiphasic insulin aspart 30 is a premixed formulation containing a soluble fraction of insulin aspart (30%) and a protamine-crystallized fraction (70%) that was developed to combine the rapid-acting and prolonged advantages of commercially available insulins. The aim of this bioequivalence study was to compare the pharmacokinetics (PKs) of GP-bi-asp and Novo-bi-asp, and evaluate the pharmacodynamic (PD) properties as well as the safety of these drugs in the hyperinsulinemic euglycemic clamp (HEC) procedure. This was a phase 1, randomized, double-blind, 2-sequence, 2-period crossover study. Thirty-four male volunteer...
Source: Clinical Pharmacology in Drug Development - September 21, 2023 Category: Drugs & Pharmacology Authors: Artem Dorotenko, Igor Makarenko, Tatiana Karonova, Ekaterina Protsenko, Maria Gefen, Gagik Galstyan, Elizaveta Antonova, Leonid Shitov, Yurij Dzhurko, Roman Drai Tags: Original Article Source Type: research

Pharmacokinetic and Bioequivalence Study of Lisinopril/Hydrochlorothiazide Tablet Under Fasting and Postprandial Conditions in Healthy Chinese Subjects
This study employed a single-center, randomized, open-label, single-dose dosing trial involving a cumulative 96 healthy adult participants (60 in the fasting group and 36 in the postprandial group). Each group comprised 2 sequence sets, and a 2-week washout period was implemented. There were no statistically significant differences in time to maximum concentration and terminal elimi nation half-life between the test and control groups under fasting and postprandial conditions (P>  .05), and the 90% CIs for area under the plasma concentration–time curve and maximum plasma concentration were within the bioequivalence r...
Source: Clinical Pharmacology in Drug Development - September 18, 2023 Category: Drugs & Pharmacology Authors: Zhuan Yang, Xiaolan Mi, Qin Li, Lu Chen, Yan Zeng, Peng Du, Lin Liu, Shijing Liu, Chen Zeng, Qian Zhang, Yan Zhou, Yun Xiong, Na Li, Qiuyuan Ze, Jiyu Chen, Yan He Tags: Original Article Source Type: research