Bioequivaelnce Study of Clarithromycin 250 mg/5 mL Powder for Oral Suspension Under Fed Conditions

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the single-dose oral bioavailability of clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories with Biaxin 250 mg/5 mL granules for oral suspension in healthy, adult, human, male subjects under fed conditions

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• Treatments: Clarithromycin

Criteria

Inclusion Criteria:

• 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 21 days prior to the commencement of the study.

Exclusion Criteria:

• 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 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.