Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

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; Clarithromycin 250 mg immediate-release oral tablet	Drug: Clarithromycin; single-dose 250 mg immediate-release oral tablets
Active Comparator: 2; Biaxin® (Clarithromycin) 250 mg tablet	Procedure: Clarithromycin; Single-dose of Clarithromycin 250 mg oral immediate-release tablets; Other Names: Biaxin®, Biaxin® Filmtabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic parameters (AUC & Cmax)	within 14 days

Collaborators and Investigators

• Sponsor: Mylan Pharmaceuticals Inc
• Collaborators: Genpharm ULC
• Investigators: Principal Investigator: Eric Sicard, M.D., Algorithme Pharma Inc

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: May 1, 2004
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Estimated): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

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-P4-057