Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State

Single Dose Crossover Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Healthy Male and Female Volunteers / Fed 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 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Clarithromycin; Drug: Clarithromycin

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Laval, Quebec, Canada, H7V 4B4
      • Algorithme Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Clarithromycin; Single-dose 500 mg immediate-release oral tablet; Drug: Clarithromycin; single-dose 500 mg immediate-release oral dose'; Other Names: Biaxin® , Biaxin® Filmtabs
Active Comparator: 2	Drug: Clarithromycin; Single-dose 500 mg immediate-release oral tablet; Drug: Clarithromycin; single-dose 500 mg immediate-release oral dose'; Other Names: Biaxin® , Biaxin® Filmtabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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%.	Within 14 days

Collaborators and Investigators

• Sponsor: Mylan Pharmaceuticals Inc
• Collaborators: Genpharm ULC

Publications and helpful links

Helpful Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (Actual): March 1, 2003
• Study Completion (Actual): March 1, 2003

Study Registration Dates

• First Submitted: March 31, 2008
• First Submitted That Met QC Criteria: March 31, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2008
• Last Update Submitted That Met QC Criteria: March 31, 2008
• Last Verified: February 1, 2003

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: CAI-P2-316