Paxil CR Bioequivalence Study Brazil

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 9, 2009

Primary Completion Date

October 5, 2009

Study Completion Date

October 5, 2009

Conditions
Depressive Disorder
Interventions
DRUG

Test formulation

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

DRUG

Reference formulation

Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)

Trial Locations (1)

30110-014

GSK Investigational Site, Belo Horizonte

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01316926 - Paxil CR Bioequivalence Study Brazil | Biotech Hunter | Biotech Hunter