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

NCT03504475 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2018-12-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Paroxetine Hydrochloride Tablet 20 mg

A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.

DRUG

Paxil® 20 mg

Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.

Sponsors & Collaborators

  • Beijing Winsunny Pharmceutical Co.,Ltd.

    collaborator UNKNOWN

  • Beijing Tongren Hospital

    lead OTHER

Principal Investigators

  • Xiuli Zhao, PhD · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-29
Primary Completion
2018-04-24
Completion
2018-06-16

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504475 on ClinicalTrials.gov