We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT00946504
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  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
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

Resource links provided by NLM:


Further study details as provided by Sandoz:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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.
  More Information

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 Submitted: July 24, 2009
First Posted: July 27, 2009
Last Update Posted: March 28, 2017
Last Verified: July 2009

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