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To Demonstrate the Effect of Food on the Bioavailability of Glipizide

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00947024
First received: July 24, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: 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.
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: The Effect of Food on the Bioavailability of Glipizide

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: November 1993
Study Completion Date: November 1993
Primary Completion Date: November 1993 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered Immediately After a Standard Breakfast.
Active Comparator: 3
10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
Drug: 10 mg Glucotrol Tablet (Roerig), Administered Immediately After a Standard Breakfast.
Experimental: 2
10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.
Drug: 10 mg Glipizide Tablet (Geneva Pharmaceutical, Inc.), Administered After an Overnight Fast.

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00947024

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: Roger D. Anderson, M.D. Novum Pharmaceutical Research Services
  More Information

No publications provided

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00947024     History of Changes
Other Study ID Numbers: 9301813
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glipizide
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014