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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00774644 |
The objective of this study is to compare the relative bioavailability of clarithromycin 500 mg tablets (Ranbaxy Laboratories Limited) with that of BIAXIN® 500 mg tablets in healthy, adult subjects under fasting conditions.
Condition | Intervention |
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Healthy |
Drug: Clarithromycin 500mg |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Crossover Assignment, Bio-equivalence Study |
Official Title: | The Objective of This Study is to Compare the Relative Bioavailability of Clarithromycin 500 mg Tablets (Ranbaxy Laboratories Limited) With That of BIAXIN® 500 mg Tablets in Healthy, Adult Subjects Under Fasting Conditions. |
Enrollment: | 33 |
Study Start Date: | December 2002 |
Study Completion Date: | February 2003 |
Primary Completion Date: | January 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
clarithromycin 500 mg tablets of Ranbaxy Laboratories Limited
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Drug: Clarithromycin 500mg |
2: Active Comparator
BIAXIN® 500 mg tablets containing clarithromycin 500mg tablets
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Drug: Clarithromycin 500mg |
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 500mg tablets of Ranbaxy Laboratories with Biaxin® tablets 500mg (containing clarithromycin 500 mg)in healthy, adult, human, male subjects under fasting conditions
Eligible subjects underwent pre-study examinations that included a physical examination, 12-lead ECG, and laboratory tests - including hematology, blood chemistries, urinalysis, infectious diseases (Hepatitis B, Hepatitis Ci HIV), and urine drugs of abuse. Laboratory testing for female subjects also included a serum pregnancy test.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Characterization of Study Group:
Clinical laboratory measurements will include the following:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Laboratories ( Tausif Monif ) |
Study ID Numbers: | B025511 |
Study First Received: | October 15, 2008 |
Last Updated: | November 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00774644 |
Health Authority: | United States: Institutional Review Board |
Clarithromycin Healthy |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |