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Clinical Trials/NCT00947024
NCT00947024CompletedPhase 1

The Effect of Food on the Bioavailability of Glipizide

Sandoz0 sites18 target enrollmentStarted: November 1993Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Sandoz
Enrollment
18
Primary Endpoint
Bioequivalence based on AUC and Cmax

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

3

Active Comparator

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

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

1

Experimental

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

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

2

Experimental

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

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

Outcomes

Primary Outcomes

Bioequivalence based on AUC and Cmax

Time Frame: 15 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Sandoz
Sponsor Class
Industry

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