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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00881179
First Posted: April 15, 2009
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sandoz
  Purpose
To demonstrate the relative bioavailability of Cilostazol 50 mg tablets under fasting conditions.

Condition Intervention Phase
Healthy Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA) Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relative Bioavailability of Clarithromycin 250 mg Tablets Under Non-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 ]

Enrollment: 24
Study Start Date: May 2002
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
Drug: Clarithromycin 250 mg Tablets (Geneva Pharmaceuticals, USA)
Active Comparator: 2
Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)
Drug: Biaxin (Clarithromycin) 250 mg Tablets (Abbott Laboratories, Inc, USA)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT00881179


Sponsors and Collaborators
Sandoz
Investigators
Principal Investigator: So Ran Hong, M.D. Novum Pharmaceutical Research Services
  More Information

Responsible Party: Eric Mittleberg, Ph.D, VP of Product Development, Sandoz Inc.
ClinicalTrials.gov Identifier: NCT00881179     History of Changes
Other Study ID Numbers: B013721
First Submitted: April 13, 2009
First Posted: April 15, 2009
Last Update Posted: March 28, 2017
Last Verified: April 2009

Keywords provided by Sandoz:
Antibiotic

Additional relevant MeSH terms:
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors