To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
March 27, 2017 updated by: Sandoz
A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions
To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 49 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.
Exclusion Criteria:
- Positive test results for HIV or hepatitis B or C.
- Treatment for drug or alcohol dependence.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
|
|
|
Experimental: 2
Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC
|
|
|
Active Comparator: 3
GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
|
|
|
Active Comparator: 4
GLUCOPHAGE XR 500 mg Extended-Release Tablets Bristol-Myers Squibb
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bioequivalence based on AUC and Cmax
Time Frame: 23 days
|
23 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: So Ran Hong, M.D., Novum Independent Institutional Review Board
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2001
Primary Completion (Actual)
June 1, 2001
Study Completion (Actual)
June 1, 2001
Study Registration Dates
First Submitted
April 16, 2009
First Submitted That Met QC Criteria
April 16, 2009
First Posted (Estimate)
April 17, 2009
Study Record Updates
Last Update Posted (Actual)
March 29, 2017
Last Update Submitted That Met QC Criteria
March 27, 2017
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B013701
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.