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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: March 27, 2017
Last verified: July 2009
July 24, 2009
March 27, 2017
October 1992
October 1992   (Final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ]
Same as current
Complete list of historical versions of study NCT00946504 on ClinicalTrials.gov Archive Site
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To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets
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
To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
  • Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
  • Experimental: 1
    Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
    Intervention: Drug: Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.)
  • Active Comparator: 2
    Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
    Intervention: Drug: Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
October 1992
October 1992   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00946504
9208525-G2
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Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz
Not Provided
Principal Investigator: Roger D. Anderson, M.D. Biodecision, Inc.
Sandoz
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP