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NCT00882882 Clinical Trial

To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions

Type II Diabetes Clinical Trial

Official title:
A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00882882
Other study ID # B013701
Secondary ID
Status Completed
Phase Phase 1
First received April 16, 2009
Last updated March 27, 2017
Start date June 2001
Est. completion date June 2001

Study information
Verified date April 2009
Source Sandoz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 2001
Est. primary completion date June 2001
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

• Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC

• GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

• GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sandoz

Outcome
Type Measure Description Time frame Safety issue
Primary Bioequivalence based on AUC and Cmax 23 days
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