Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State
NCT ID: NCT00648128
Last Updated: 2008-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2003-03-31
2003-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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2
Clarithromycin
single-dose 500 mg immediate-release oral dose'
1
Clarithromycin
Single-dose 500 mg immediate-release oral tablet
Interventions
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Clarithromycin
Single-dose 500 mg immediate-release oral tablet
Clarithromycin
single-dose 500 mg immediate-release oral dose'
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
50 Years
ALL
Yes
Sponsors
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Genpharm ULC
INDUSTRY
Mylan Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Genpharm ULC
Principal Investigators
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Eric Sicard, M.D.
Role: PRINCIPAL_INVESTIGATOR
Algorithme Pharma Inc
Locations
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Algorithme Pharma
Laval, Quebec, Canada
Countries
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Related Links
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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
Other Identifiers
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CAI-P2-316
Identifier Type: -
Identifier Source: org_study_id