Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-26 @ 7:49 AM
Study NCT ID:
NCT01074450
Status:
COMPLETED
Last Update Posted:
2010-04-30
First Post:
2010-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
Sponsor:
Teva Pharmaceuticals USA
Organization:
Study Overview
Official Title:
A Relative Bioavailability Study of 0.25 mg Pramipexole Dihydrochloride Tablets Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2010-04
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 object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc. with that of Mirapex® Tablets 0.25 mg distributed by Boehringer Ingelheim Pharmaceuticals, Inc. following a single oral dose in healthy adults 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:
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?: