Comparative Bioavailability Study of Clarithromycin 250 mg Tablets
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Procedure: Clarithromycin Drug: Clarithromycin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Single Dose Crossover Replicate Comparative Bioavailability Study of Clarithromycin 250 mg Tablets in Healthy Male and Female Volunteers Under Fasted Conditions |
- Pharmacokinetic parameters (AUC & Cmax) [ Time Frame: within 14 days ] [ Designated as safety issue: No ]
| Enrollment: | 32 |
| Study Start Date: | May 2004 |
| Study Completion Date: | June 2004 |
| Primary Completion Date: | June 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Biaxin®, Biaxin® Filmtabs
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Elliot Offman, Director, Biopharmaceutics, Genpharm ULC |
| ClinicalTrials.gov Identifier: | NCT00648830 History of Changes |
| Other Study ID Numbers: | CAI-P4-057 |
| Study First Received: | March 31, 2008 |
| Last Updated: | March 31, 2008 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Clarithromycin Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013