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

Sandoz

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.); Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00946504

9208525-G2

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

1

Experimental group

Description:

Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)

Treatment:

Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)

2

Active Comparator group

Description:

Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Treatment:

Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)