Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions
NCT ID: NCT00775372
Last Updated: 2008-10-20
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
NA
40 participants
INTERVENTIONAL
2005-09-30
2005-12-31
Brief Summary
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Detailed Description
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A single oral dose of clarithromycin 250 mg/5 mL was administered during each period under supervision of a trained Medical Officer.
During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology \& biochemical parameters) were performed again at the end of the study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories
Clarithromycin 250mg/5mL
2
Biaxin® granules 250 mg/5 mL oral suspension
Clarithromycin 250mg/5mL
Interventions
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Clarithromycin 250mg/5mL
Eligibility Criteria
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Inclusion Criteria
* Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
* Have voluntarily given written informed consent to participate in this study.
* Be of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
Exclusion Criteria
* History of severe diarrhoea within 2 weeks preceding Day 1 of this study.
* Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations
* Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
* Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for haemoglobin, total white blood cells count, differential WBC count or platelet count.
* Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
* Presence of values which are significantly different from normal reference ranges (as defined in Appendix 5) and/or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
* Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
* Clinically abnormal ECG or Chest X-ray.
* QTc interval beyond normal limits
* History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
* History of any psychiatric illness which may impair the ability to provide written informed consent.
* Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
* History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period.
* Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
* Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
* A haemoglobin concentration of less than 7 % of lower limit of reference range e.g. 13 gm % for reference range of 14-18 gm at screening.
18 Years
45 Years
MALE
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Laboratories
Locations
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Ranbaxy Research Laboratories
Gurgaon, Haryana, India
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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CPU-N-015/CLARI-250/05
Identifier Type: -
Identifier Source: org_study_id