Bioequivalence Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fasting Conditions

Launched by RANBAXY LABORATORIES LIMITED · Oct 16, 2008

Keywords

ClinConnect Summary

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 clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin® granules 250 mg/5 mL oral suspension (containing clarithromycin 250 mg/5mL) of Abbott Laboratories in healthy, adult, human, male subjects under fasting conditions.

A single oral dose of clarithromycin 250-mg/5 mL was administered during each period of the study under supervision of a trained Medical Officer.

D...

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Be in the age range of 18-45 years.
• • 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 examination of the subjects performed within 14 days prior to the commencement of the study.
• Exclusion Criteria:
• • 1. History of allergy to clarithromycin, erythromycin and related macrolides.
• • 2. History of severe diarrhoea within 2 weeks preceding Day 1 of this study.
• • 3. Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• • 4. Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• • 5. 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.
• • 6. Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids)
• • 7. 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.
• • 8. Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), glucose (positive) or protein (positive).
• • 9. Clinically abnormal ECG or Chest X-ray.
• • 10. QTc interval beyond normal limits.
• • 11. History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
• • 12. History of any psychiatric illness which might have impair the ability to provide written informed consent.
• • 13. Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
• • 14. 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.
• • 15. Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
• • 16. Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
• • 17. Subjects who, through completion of this study, would have donated and/or lost more than 350 mL of blood in the past 3 months.