NCT00549666View on ClinicalTrials.gov

A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

August 31, 2007

Primary Completion Date

December 31, 2007

Study Completion Date

December 31, 2007

Conditions

Pharmacokinetics

Interventions

DRUG

Lurasidone 40 mg

Lurasidone 40 mg days 12-21 once daily

DRUG

Placebo 40 mg

Placebo 40 mg once daily during treatment period

DRUG

Ortho Tri-Cyclen

Ortho Tri-Cyclen during 28-day lead in period

Trial Locations (1)

92123

Covance Global Clinical Pharmacology, Inc., San Diego

All Listed Sponsors

lead

Sumitomo Pharma America, Inc.

INDUSTRY

NCT00549666 - A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects | Biotech Hunter | Biotech Hunter