Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-31 @ 9:02 AM
Study NCT ID:
NCT01074632
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2010-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Calories and Fat Content on the Pharmacokinetics of Lurasidone HCl
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label Study to Determine the Effect of Calories and Fat Content on the Pharmacokinetics of Repeated Dose Lurasidone 120 mg in Subjects With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder.
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:
None
Brief Summary:
The objective of this study is to evaluate the effect of calorie and fat content on the pharmacokinetics of Lurasidone HCl in subjects with schizophrenia, schizoaffective disorder, or schizophreniform disorder.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: