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OpenTrials
Completed

NCT Number: NCT00947024

To Demonstrate the Effect of Food on the Bioavailability of Glipizide

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

Completed

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Drug

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

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

The Effect of Food on the Bioavailability of Glipizide

Important dates

Study start
1993
Primary completion
1993
Study completion
1993
First posted
Jul 27, 2009
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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