To Demonstrate the Effect of Food on the Bioavailability of Glipizide

Sandoz

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.; Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.; Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00947024

9301813

Details and patient eligibility

About

To demonstrate the effect of food on the bioavailability of Glipizide.

Enrollment: 18 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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18 participants in 3 patient groups

1

Experimental group

Description:

10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.

Treatment:

Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.

3

Active Comparator group

Description:

10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.

Treatment:

Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.

2

Experimental group

Description:

10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.

Treatment:

Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.