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Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State

This study has been completed.
Genpharm ULC
Information provided by:
Mylan Pharmaceuticals Identifier:
First received: March 31, 2008
Last updated: NA
Last verified: February 2003
History: No changes posted

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period, two-treatment crossover bioequivalence study conducted by Eric Sicard, M.D. at Algorithme Pharma Inc. Montreal, Canada.

Statistical analysis of the data reveals that 90% confidence intervals are within the acceptable bioequivalent range of 80% and 125% for the natural log transformed parameters AUCT, AUCI and Cmax. This study demonstrates that Genpharm's clarithromycin 500 mg tablets are bioequivalent to Biaxin® filmtab® 500 mg tablets (Abbott Laboratories USA) administered under fed conditions.

Condition Intervention Phase
Healthy Drug: Clarithromycin Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fed State

Resource links provided by NLM:

Further study details as provided by Mylan Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic; The 90% confidence interval for the exponential of the difference between the Test and the Reference product for the ln-transformed parameters Cmax, AUCT and AUC∞ should be between 80 and 125%. [ Time Frame: Within 14 days ]

Enrollment: 44
Study Start Date: March 2003
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2 Drug: Clarithromycin
single-dose 500 mg immediate-release oral dose`
Other Name: Biaxin® , Biaxin® Filmtabs
Experimental: 1 Drug: Clarithromycin
Single-dose 500 mg immediate-release oral tablet


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects meeting all of the following criteria may be included in the study:

Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject

Males or females aged from 18 to 50 years with a body mass index (BMI) within 19-30; demographic data (sex, age, ethnic group, body weight, height and smoking habits) will be recorded and reported in the final report

Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance and must be recorded as such in the CRF (laboratory tests are presented in section 7.1.3)

Healthy according to the laboratory results and physical examination

Exclusion Criteria:

Severe hypersensitivity reactions (like angioedema) to any drugs

Presence or history of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects

Presence or history of significant cardiovascular, pulmonary, hematologic, neurologic, psychiatric, endocrine, immunologic or dermatologic disease

Females who are pregnant, lactating or are likely to become pregnant during the study periods.

Females of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the study.

Positive pregnancy test before or during the study.

Use of the following products (astemizole, terfenadine, cisapride or pimozide) in the previous 14 days before day 1 of the study

Maintenance therapy with any drug, or significant history of drug dependency, alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic), or serious psychological disease

Any clinically significant illness in the previous 28 days before day 1 of this study

Use of enzyme-modifying drugs in the previous 28 days before day 1 of this study (all barbiturates, corticosteroids, phenylhydantoins, etc.)

Participation in another clinical trial in the previous 28 days before day 1 of this study

Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before day 1 of this study

Positive urine screening of drugs of abuse (drug names are presented in section 7.1.4)

Positive results to HIV, HBsAg or anti-HCV tests

History of fainting upon blood sampling

  Contacts and Locations
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Please refer to this study by its identifier: NCT00648128

Canada, Quebec
Algorithme Pharma
Laval, Quebec, Canada, H7V 4B4
Sponsors and Collaborators
Mylan Pharmaceuticals
Genpharm ULC
Principal Investigator: Eric Sicard, M.D. Algorithme Pharma Inc
  More Information

Additional Information:
Responsible Party: Elliot Offman, Director, Biopharmaceutics, Genpharm ULC Identifier: NCT00648128     History of Changes
Other Study ID Numbers: CAI-P2-316
Study First Received: March 31, 2008
Last Updated: March 31, 2008

Additional relevant MeSH terms:
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 processed this record on September 21, 2017