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OpenTrials
Completed

NCT Number: NCT00946504

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

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

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

Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)

Drug

Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

A Two-Way Crossover Bioequivalence Study Comparing Single 10 mg Doses of Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets

Important dates

Study start
1992
Primary completion
1992
Study completion
1992
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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