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

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ClinicalTrials.gov Identifier: NCT00946504
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : October 1992
Primary Completion Date : October 1992
Study Completion Date : October 1992

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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.)



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946504


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

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
First Posted: July 27, 2009    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: July 2009

Additional relevant MeSH terms:
Glipizide
Hypoglycemic Agents
Physiological Effects of Drugs