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

An Open Label, Balanced, Randomised, Two-Treatment, Four-Period, Two- Sequence, Single-Dose, Crossover Fully Replicated, 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 in Healthy, Adult,Human, Male Subjects Under Fed Conditions.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Clarithromycin 250mg/5mL

Detailed Description

The study was conducted as an open label, balanced, randomised, two-treatment, four-period, two-sequence, single-dose, crossover fully replicated, 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 in healthy, adult, human, male subjects under fed conditions

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

During the course of study, the safety parameters including vital signs, physical examination, medical history, clinical laboratory and safety tests (haematology, biochemical parameters) were assessed and, clinical laboratory safety tests (hematology & biochemical parameters) were performed again at the end of the study.

• Study Type: Interventional
• Enrollment: 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Gurgaon, Haryana, India
      • Ranbaxy Research Laboratories

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories	Drug: Clarithromycin 250mg/5mL
Active Comparator: 2; Biaxin® granules 250 mg/5 mL oral suspension	Drug: Clarithromycin 250mg/5mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

• Sponsor: Ranbaxy Laboratories Limited

Publications and helpful links

Helpful Links

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Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): December 1, 2005

Study Registration Dates

• First Submitted: October 16, 2008
• First Submitted That Met QC Criteria: October 17, 2008
• First Posted (Estimate): October 20, 2008

Study Record Updates

• Last Update Posted (Estimate): October 20, 2008
• Last Update Submitted That Met QC Criteria: October 17, 2008
• Last Verified: October 1, 2008

More Information

Terms related to this study

• Keywords: Bioequivalence study of clarithromycin 250mg/5mL powdder
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Clarithromycin
• Other Study ID Numbers: CPU-N-015/CLARI-250/05