NCT03504475View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

April 24, 2018

Study Completion Date

June 16, 2018

Conditions
Major Depressive DisorderObsessive-Compulsive DisorderPanic DisorderSocial Anxiety DisorderGeneralized Anxiety Disorder
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.）.

Trial Locations (2)

100730

Beijing TongRen Hospital, Beijing

Unknown

Beijing TongRen Hospital, Beijing

All Listed Sponsors
collaborator

Beijing Winsunny Pharmceutical Co.,Ltd.

UNKNOWN

lead

Beijing Tongren Hospital

OTHER

NCT03504475 - Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers | Biotech Hunter | Biotech Hunter