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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
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Clarithromycin 250 mg Tablets (Geneva, USA)
Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
 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: A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Fasting Conditions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Bioequivalence based on AUC and Cmax [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2002
Study Completion Date: July 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clarithromycin 250 mg Tablets (Geneva, USA)
 Drug: Clarithromycin 250 mg Tablets (Geneva, USA)
Active Comparator: 2
Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)
 Drug: Biaxin 250 mg Tablets (Abbott Laboratories, Inc, USA)

  Eligibility

Ages Eligible for Study:   19 Years to 54 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881738

Sponsors and Collaborators
Sandoz Inc.
Investigators
Principal Investigator: So Ran Hong, 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: NCT00881738     History of Changes
Other Study ID Numbers: B013720
Study First Received: April 13, 2009
Last Updated: April 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Clarithromycin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013