To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions
Overview[ - collapse ][ - ]
Purpose | To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions. |
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Condition | Type II Diabetes |
Intervention | Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb |
Phase | Phase 1 |
Sponsor | Sandoz Inc. |
Responsible Party | Sandoz |
ClinicalTrials.gov Identifier | NCT00882882 |
First Received | April 16, 2009 |
Last Updated | April 16, 2009 |
Last verified | April 2009 |
Tracking Information[ + expand ][ + ]
First Received Date | April 16, 2009 |
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Last Updated Date | April 16, 2009 |
Start Date | June 2001 |
Estimated Primary Completion Date | June 2001 |
Current Primary Outcome Measures | Bioequivalence based on AUC and Cmax [Time Frame: 23 days] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | To Demonstrate the Relative Bioavailability of Metformin HCL 500 mg Extended Release (XR) Tablets Under Fasting Conditions |
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Official Title | A Relative Bioavailability Study of Metformin HCL 500 mg XR Tablets Under Fasting Conditions |
Brief Summary | To demonstrate the relative bioavailability of Metformin HCl 500 mg XR tablets under fasting conditions. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 1 |
Study Design | Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type II Diabetes |
Intervention | Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC Drug: Metformin HCL 500 mg Extended-Release Tablets, Geneva PTC Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb Drug: GLUCOPHAGE XR 500 mg ER Tablets Bristol-Myers Squibb |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 16 |
Estimated Completion Date | June 2001 |
Estimated Primary Completion Date | June 2001 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 19 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00882882 |
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Other Study ID Numbers | B013701 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Sandoz |
Study Sponsor | Sandoz Inc. |
Collaborators | Not Provided |
Investigators | Principal Investigator: So Ran Hong, M.D. Novum Independent Institutional Review Board |
Verification Date | April 2009 |