Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers

Major Depressive Disorder Clinical Trial

Official title: An Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study of Paroxetine Hydrochloride 20 mg Tablets and Paxil® Under Fasting Conditions and Under Fed Conditions in Chinese Healthy Volunteers

Status Completed

Clinical Trial Summary

The objective of this study is to compare the rate and extent of absorption of paroxetine hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under fed conditions.

Clinical Trial Description

The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence Study with a washout period of 14 days. During each session, the subjects will be administered a single dose of 20 mg Paroxetine (one Paroxetine Hydrochloride Tablet 20mg or one Paxil® Tablet 20 mg) under Fasting and Fed conditions. Venous blood samples will be collected at pre-dose (0 h), and up to 96 h post dose. ;

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Generalized Anxiety Disorder
• Major Depressive Disorder
• Obsessive-Compulsive Disorder
• Panic Disorder
• Phobia, Social
• Social Anxiety Disorder

• NCT number: NCT03504475
• Study type: Interventional
• Source: Beijing Tongren Hospital
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2018
• Completion date: June 16, 2018