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

NCT00775255 | Completed DMC

• 1 other identifier: CPU-M-025/CLARI-250/05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 a 250 mg/5 mL dose in healthy, adult, human, male subjects under fasting conditions.

Conditions

Healthy

Keywords

Bioequiavelnce clarithromycin

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories

Drug: clarithromycin 250 mg/5 mL powder for oral suspension

2

ACTIVE COMPARATOR

Biaxin® granules 250 mg/5 mL oral suspension

Drug: clarithromycin 250 mg/5 mL powder for oral suspension

Interventions

clarithromycin 250 mg/5 mL powder for oral suspension DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Unknown Facility

Gurgaon, Haryana, India

Location

Related Links

• Related Info
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MeSH Terms

Interventions

Clarithromycin; Powders; Suspensions

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations; Colloids; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2005
• Study Completion: December 1, 2005
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

IN (1)