Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
Study NCT ID:
NCT00840606
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2009-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buspirone Hydrochloride 30mg Tablets, Fasting
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 30 mg Buspirone Hydrochloride Tablets Under Fasting 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:
This study will compare the relative bioavailability (rate and extent of absorption) of 30 mg Buspirone Hydrochloride Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 30 mg BUSPAR® Tablets by Bristol-Myers Squibb Company following a single oral dose (1 x 30 mg tablet) in healthy adult volunteers under fasting 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:
False
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?: