Official Title: “Randomized Single Dose Crossover Replicate Comparative Bioavailability Study of Clarithromycin 250 mg Tablets in Healthy Male and Female Volunteers Under Fasted Conditions”

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-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 250 mg tablets are bioequivalent to Biaxin® filmtab® 250 mg tablets (Abbott Laboratories USA) administered under fasted conditions.

Study Type: Interventional

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

Study Primary Completion Date: June 2004

Intervention(s) in this Clinical Trial

• Procedure: Clarithromycin
  • Single-dose of Clarithromycin 250 mg oral immediate-release tablets
• Drug: Clarithromycin
  • single-dose 250 mg immediate-release oral tablets

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Clarithromycin 250 mg immediate-release oral tablet
• Active Comparator: 2
  • Biaxin® (Clarithromycin) 250 mg tablet

Primary Measures

• Pharmacokinetic parameters (AUC & Cmax)
  • Time Frame: within 14 days
    Safety Issue?: No

Inclusion Criteria:

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

• Availability of volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form (ICF) duly signed by the volunteer
• Males or females aged of at least 18 years with a body mass index (BMI) greater or equal to 19 and below 30 kg/m2
• Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance (laboratory tests are presented in section 6.1.1.3)
• Healthy according to the laboratory results and physical examination
• Light , non or ex smokers. Light smokers are defined as someone smoking 10 cigarettes or less per day, and ex smokers are defined as someone who completely stopped smoking for at least 3 months

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
• Presence of significant heart disease or disorder according to ECG
• Females who are pregnant, lactating or are likely to become pregnant during the study
• Females of childbearing potential or females taking systemic contraceptives who refuse to use one of the acceptable contraceptive regimen (described in section 5.4.9) throughout the study
• Positive HCG beta serum pregnancy test before or during the study
• Maintenance therapy with any drug, or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
• 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 (drugs listing is presented in section 6.1.1.4)
• Positive results to HIV, HBsAg or anti-HCV tests

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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/NCT00648830

Study ID Number: CAI-P4-057

ClinicalTrials.gov Identifier: NCT00648830

Health Authority: Canada: Health Canada

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