To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets

Phase 1

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.); Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

• Registration Number: NCT00946504
• Lead Sponsor: Sandoz

Brief Summary

To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 1992-10
• Primary Completion: 1992-10
• Study Completion: 1992-10
• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

Inclusion Criteria

• No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

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Exclusion Criteria

• Positive test results for HIV or hepatitis B or C.
• Treatment for drug or alcohol dependence.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)	Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
2	Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)	Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Primary Outcome Measures

Name	Time	Method
Bioequivalence based on AUC and Cmax	9 days