Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT00648518
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fasting Study of Metformin Hydrochloride ER Tablets 750 mg and Glucophage® XR Tablets 750 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Fasting In Vivo Bioequivalence Study of Metformin Hydrochloride ER Tablets (750 mg; Mylan) and Glucophage® XR Tablets (750 mg; Bristol-Myers Squibb) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-04
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 objective of this study was to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 750 mg (1 x 750 mg) dose administered under fasting conditions.
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?: