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
  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:


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
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: 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
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014