Bioequivalence Analysis of 2 Dapoxetine Hydrochloride Formulations in Healthy Chinese Male Volunteers Under Fed and Fasting Conditions: A Randomized, Open‐Label, 2‐Sequence, 2‐Period, 2‐Way Crossover Study

• Published in: Clinical pharmacology in drug development Vol. 10; no. 4; pp. 384 - 392
• Main Authors: Yan, Keyu, Ju, Gehang, Tan, Qiong, Zeng, Lijiao, Qiu, Wen
• Format: Journal Article
• Language: English
• Published: United States Wiley Subscription Services, Inc 01.04.2021
• Subjects: Adolescent; Adult; Area Under Curve; Asians; Benzylamines - administration & dosage; Benzylamines - pharmacokinetics; Bioequivalence; Chromatography, High Pressure Liquid; Cross-Over Studies; dapoxetine hydrochloride; Fasting; food effect; Food-Drug Interactions; HPLC‐MS/MS; Humans; Male; Naphthalenes - administration & dosage; Naphthalenes - pharmacokinetics; pharmacokinetics; Serotonin Uptake Inhibitors - administration & dosage; Serotonin Uptake Inhibitors - pharmacokinetics; Tandem Mass Spectrometry; Therapeutic Equivalency; Young Adult; pharmacokinetics; dapoxetine hydrochloride; HPLC-MS/MS; food effect; bioequivalence

This study assessed whether the reference and test formulations of dapoxetine hydrochloride were bioequivalent under fed and fasting conditions postadministration of a single dose as well as evaluated the safety profile of these 2 formulations. This study was a randomized, single‐center, 2‐period, o...