Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-29 @ 5:30 PM
Study NCT ID:
NCT01082250
Status:
COMPLETED
Last Update Posted:
2011-09-08
First Post:
2010-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Bioequivalence Of Two Different Lurasidone Formulations In Patients
Sponsor:
Sumitomo Pharma America, Inc.
Organization:
Study Overview
Official Title:
AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, 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:
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Detailed Description:
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
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?: