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

NCT00549666 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-09-14

No results posted yet for this study

Summary

A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen

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

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director, MD · Sumitomo Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00549666 on ClinicalTrials.gov