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To Demonstrate the Effect of Food on the Bioavailability of Glipizide

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ClinicalTrials.gov Identifier: NCT00947024
Recruitment Status : Completed
First Posted : July 27, 2009
Last Update Posted : March 28, 2017
Sponsor:
Information provided by:
Sandoz

Brief Summary:
To demonstrate the effect of food on the bioavailability of Glipizide.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Food on the Bioavailability of Glipizide
Study Start Date : November 1993
Actual Primary Completion Date : November 1993
Actual Study Completion Date : November 1993

Resource links provided by the National Library of Medicine

Drug Information available for: Glipizide

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Bioequivalence based on AUC and Cmax [ Time Frame: 15 days ]


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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): NCT00947024


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

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00947024     History of Changes
Other Study ID Numbers: 9301813
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