Paxil CR Bioequivalence Study Brazil - Fed Administration

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 20, 2009

Primary Completion Date

November 16, 2009

Study Completion Date

November 16, 2009

Conditions
Depressive Disorder
Interventions
DRUG

Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico

Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

DRUG

Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada

Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)

Trial Locations (1)

30110-014

GSK Investigational Site, Belo Horizonte

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01339247 - Paxil CR Bioequivalence Study Brazil - Fed Administration | Biotech Hunter | Biotech Hunter