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

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00946504
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
 Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Drug Information available for: Glipizide
U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: October 1992
Study Completion Date: October 1992
Primary Completion Date: October 1992 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
 Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
Active Comparator: 2
Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
 Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946504

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Roger D. Anderson, M.D. Biodecision, Inc.
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00946504     History of Changes
Other Study ID Numbers: 9208525-G2
Study First Received: July 24, 2009
Last Updated: July 24, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013