Status:
COMPLETED
Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief Summary
To compare the single-dose oral bioavailability of clarithromycin 250-mg/5 mL powder for oral suspension of Ranbaxy Laboratories with that of Abbott Laboratories (Biaxin®) following administration of ...
Detailed Description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study on clarithromycin formulations comparing clarithr...
Eligibility Criteria
Inclusion
- Be in the age range of 18-45 years.
- 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 14 days prior to the commencement of the study.
Exclusion
- History of allergy to clarithromycin, erythromycin and related macrolides.
- 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 were 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 were 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 might have 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.
- Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00775255
Start Date
September 1 2005
End Date
December 1 2005
Last Update
October 20 2008
Active Locations (1)
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1
Gurgaon, Haryana, India