Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-03-30 @ 9:04 PM
Study NCT ID:
NCT00549666
Status:
COMPLETED
Last Update Posted:
2011-09-14
First Post:
2007-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Placebo-Controlled, Two-Period, Crossover Study to Evaluate the Effect of Lurasidone HCl on Oral Contraceptive Pharmacokinetics in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OC-DDI
Brief Summary:
A Phase 1, drug, drug, interaction study between Lurasidone HCl and Ortho-tri cyclen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: