Bioequivalence Study of Clarithromycin 250mg Tablets Under Fasting Conditions
NCT ID: NCT00774189
Last Updated: 2008-10-17
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
32 participants
INTERVENTIONAL
2003-07-31
2003-11-30
Brief Summary
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Detailed Description
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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 tablets of Ranbaxy Laboratories
clarithromycin 250 mg tablets
2
Biaxin 250 mg tablets
clarithromycin 250 mg tablets
Interventions
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clarithromycin 250 mg tablets
Eligibility Criteria
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Inclusion Criteria
2. Be neither overweight nor underweight for his/her height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
3. Have voluntarily given written informed consent to participate in this study.
4. Be of normal health as determined by medical history and physical
5. Examination of the subjects performed .within 14 days prior to the commencement of the study.
6. If female and:
Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or\~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Exclusion Criteria
2. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
3. Presence of disease markers of HIV 1 and 2, Hepatitis B and C viruses and syphilis infection.
4. Female volunteers demonstrating a positive pregnancy screen.
5. Female volunteers who are currently breastfeeding.
6. Presence of values' which are clinically significantly different from normal reference ranges for haemoglobin, total white blood cells count, differential WBC count and platelet count
7. Positive for urinary screen testing of drugs of abuse (opiates and cannabinoids
8. Presence of values which are significantly different from normal.reference ranges (as defined in Appendix 5) for se- rum creatinine, blood urea nitrogen serum aspartate aminotransferase (AST), serum alanine aminotranferase (ALT), serum alkaline phosphatase, serum billrubin, plasma glucose and serum cholesterol
9. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), epithelial cells (\>4/HPF), glucose, (positive) and protein (positive).
10. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or hematological disease, diabetes or glaucoma.
11. History of any psychiatric illness. which may impair the ability to provide written informed consent.
12. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
13. 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.
14. Use of any enzyme modifying drugs within 30 days prior to Day I of this study
15. Participation in any clinical trial within 12 weeks preceeding day 1 of study
16. Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in past 3 months
18 Years
45 Years
MALE
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Labs
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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020/CLARI-250/03
Identifier Type: -
Identifier Source: org_study_id