To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Sandoz
ClinicalTrials.gov Identifier:
NCT00881738
First received: April 13, 2009
Last updated: April 15, 2009
Last verified: April 2009

April 13, 2009
April 15, 2009
June 2002
June 2002   (final data collection date for primary outcome measure)
Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00881738 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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To Demonstrate the Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions
A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

To demonstrate the relative bioavailability of Clarithromycin 250 mg tablets under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • Drug: Clarithromycin 250 mg Tablets (Geneva, USA)
  • Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
  • Experimental: 1
    Clarithromycin 250 mg Tablets (Geneva, USA)
    Intervention: Drug: Clarithromycin 250 mg Tablets (Geneva, USA)
  • Active Comparator: 2
    Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
    Intervention: Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2002
June 2002   (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.
Both
19 Years to 54 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00881738
B013720
Not Provided
Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
Sandoz Inc.
Not Provided
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
Sandoz
April 2009

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