Official Title: “Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fasting State”

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 fasting conditions. Sixty-four (64) 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 fasting conditions.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: July 2003

Intervention(s) in this Clinical Trial

• Drug: Clarithromycin
  • Single-dose 500 mg immediate-release oral tablet
• Drug: Clarithromycin
  • Single-dose 500 mg immediate-release oral dose

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary 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: 14 days
    Safety Issue?: No

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 55 years with a body mass index (BMI) greater than or equal to 19 and below 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:

• Significant history of hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or any related products as well as 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 phases
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Eric Sicard, M.D. Principal Investigator Algorithme Pharma Inc  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00648960

Study ID Number: CAI-P3-134

ClinicalTrials.gov Identifier: NCT00648960

Health Authority: Canada: Health Canada

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