Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-26 @ 2:52 PM
Study NCT ID:
NCT01089166
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2010-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
Sponsor:
Torrent Pharmaceuticals Limited
Organization:
Study Overview
Official Title:
To Compare the Bioavailability of Extended Release Metformin HCl Tablet(Test Formulation, Torrent Pharmaceuticals Ltd.,India) Versus Glucophage XR® Tablets ( Reference Formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers Under Fasting Condition
Status:
COMPLETED
Status Verified Date:
2010-03
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:
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in Healthy Human Volunteers under fasting condition.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.
Study Design: An Open-Label, Randomised, 2-Period, 2-Treatment,Crossover Study under fasting condition.
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?: