Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

Launched by MYLAN PHARMACEUTICALS INC · Mar 31, 2008

Keywords

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Eligibility criteria

• 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 55 years with a body mass index (BMI) greater than or equal to 19 and below 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:
• • 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
• • Females who are pregnant, lactating or are likely to become pregnant during the study phases
• • 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