Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 11:39 PM
Study NCT ID:
NCT00829894
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
Randomized, 2-Way Crossover, Bioequivalence Study of Risperidone 1 mg Tablets and Risperdal® 1 mg Tablets Administered as a 1 x 1 mg Tablets in Subjects Under Fed Conditions
Status:
COMPLETED
Status Verified Date:
2024-08
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 was to compare the rate and extent of absorption of risperidone 1 mg tablets (test) versus Risperdal® (reference) administered as a 1 x 1 mg tablets under fed conditions.
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Statistical Methods: FDA bioequivalence statistical methods
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?: