Pharmacokinetic Bioequivalence and Safety Assessment of Two Venlafaxine Hydrochloride Extended-Release Capsules in Healthy Chinese Subjects Under Fed Conditions: A Randomized, Open-Label, Single-Dose, Crossover Study

• Published in: Drugs in R&D Vol. 24; no. 2; pp. 275 - 283
• Main Authors: He, Yingxia, Wang, Jie, Yao, Fang, Lu, Pan, Xie, Yafang, Li, Xiuwen, Liu, Qiangwei, Liu, Yang, Cao, Dan, Liang, Jun, Tian, Dan, Liu, Guan
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.06.2024; Springer Nature B.V; Adis, Springer Healthcare
• Subjects: Adult; Antidepressants; Area Under Curve; Biochemistry; Bioequivalence; Capsules; China; Cross-Over Studies; Delayed-Action Preparations - administration & dosage; Delayed-Action Preparations - adverse effects; Delayed-Action Preparations - pharmacokinetics; Drug dosages; Drugs, Generic - administration & dosage; Drugs, Generic - adverse effects; Drugs, Generic - pharmacokinetics; East Asian People; Enzymes; FDA approval; Female; Healthy Volunteers; Hematology; Humans; Internal Medicine; Male; Medical laboratories; Medicine; Medicine & Public Health; Mental depression; Middle Aged; Oral administration; Original; Original Research Article; Pharmaceutical industry; Pharmacology/Toxicology; Pharmacotherapy; Plasma; Therapeutic Equivalency; Variance analysis; Venlafaxine Hydrochloride - administration & dosage; Venlafaxine Hydrochloride - adverse effects; Venlafaxine Hydrochloride - pharmacokinetics; Young Adult; China; United States > US

Background and Objective Venlafaxine hydrochloride extended-release (ER) capsules are commonly used to treat depression and anxiety disorders. Evaluation of the bioequivalence of generic formulations with reference products is essential to ensure therapeutic equivalence. The objective of this study...