Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

NCT ID: NCT00648830

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2004-06-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Clarithromycin 250 mg immediate-release oral tablet

Group Type: EXPERIMENTAL

Clarithromycin

Intervention Type: DRUG

single-dose 250 mg immediate-release oral tablets

2

Biaxin® (Clarithromycin) 250 mg tablet

Group Type: ACTIVE_COMPARATOR

Clarithromycin

Intervention Type: PROCEDURE

Single-dose of Clarithromycin 250 mg oral immediate-release tablets

Interventions

Clarithromycin

Single-dose of Clarithromycin 250 mg oral immediate-release tablets

Intervention Type: PROCEDURE

Clarithromycin

single-dose 250 mg immediate-release oral tablets

Intervention Type: DRUG

Other Intervention Names

Biaxin®, Biaxin® Filmtabs

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genpharm ULC

INDUSTRY

Sponsor Role: collaborator

Mylan Pharmaceuticals Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Genpharm ULC

Principal Investigators

Eric Sicard, M.D.

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

Algorithme Pharma

Montreal, Quebec, Canada

Countries

Canada

Related Links

http://www.mpibiostudies.com

Mylan Pharmaceuticals Inc. - Clinical Trial Results

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

http://www.fda.gov/opacom/7alerts.html

Recalls, Market Withdrawals and Safety Alerts

Other Identifiers

CAI-P4-057

Identifier Type: -

Identifier Source: org_study_id