Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-29 @ 5:42 PM
Study NCT ID:
NCT00648492
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2008-03-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Study Metformin Hydrochloride ER Tablets 500 mg and Glucophage® XR 500 mg
Sponsor:
Mylan Pharmaceuticals Inc
Organization:
Study Overview
Official Title:
Single-Dose Food In Vivo Bioequivalence Study Metformin Hydrochloride ER Tablets (500 mg; Mylan) and Glucophage® XR (500 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 is to investigate the bioequivalence of Mylan's metformin hydrochloride ER tablets to Bristol-Myers Squibb's Glucophage® XR tablets following a single, oral 500 mg (1 x 500 mg) dose administered under fed 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?: