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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00775255 |
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.
Condition | Intervention |
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Healthy |
Drug: clarithromycin 250 mg/5 mL powder for oral suspension |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | 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 in Healthy, Adult, Human, Male Subjects Under Fasting Conditions. |
Enrollment: | 40 |
Study Start Date: | September 2005 |
Study Completion Date: | December 2005 |
Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
clarithromycin 250 mg/5 mL powder for oral suspension of Ranbaxy Laboratories
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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 |
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.
During the course of the study safety parameters assessed were vital signs, twelve-lead ECG, clinical examination, medical history, clinical laboratory safety tests (hematology, biochemical parameters and urine analysis) at base line and hematology and biochemical parameters at 24 hours post dose of the last period of the study. Twelve-lead ECG was recorded at 4 and 8 hours post-dose in each period.
A Validated analytical method was used for the analysis of Clarithromycin in human plasma. Pharmacokinetic and statistical analysis was performed to conclude the bioequivalence.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Laboratories, ( Dr. Tausif Monif ) |
Study ID Numbers: | CPU-M-025/CLARI-250/05 |
Study First Received: | October 16, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00775255 |
Health Authority: | India: Drugs Controller General of India |
Bioequiavelnce clarithromycin |
Clarithromycin Healthy |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |