Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

May 30, 2018

Primary Completion Date

August 3, 2018

Study Completion Date

August 3, 2018

Conditions
Anxiety Disorders
Interventions
DRUG

Paroxetine IR tablets A

Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.

DRUG

Paroxetine IR tablets B

Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.

Trial Locations (1)

201508

GSK Investigational Site, Shanghai

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03329573 - Bioequivalence Study of Paroxetine Immediate Release (IR) Tablets Manufactured in GlaxoSmithKline Tianjin (GSKT) and Mississauga Sites in Healthy Chinese Subjects | Biotech Hunter | Biotech Hunter