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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00774189 |
The objective of the study was to compare the single-dose oral bioavailability of Clarithromycin 250 mg tablets of Ranbaxy Laboratories with Biaxin 250 mg tablets of Abbott Laboratories in healthy, adult, human subjects under fasting conditions
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: clarithromycin 250 mg tablets |
Phase I |
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 Tablets of Ranbaxy Laboratories With Biaxin 250 mg Tablets of Abbott Laboratories in Healthy, Adult, Human Subjects Under Fasting Conditions |
Enrollment: | 32 |
Study Start Date: | July 2003 |
Study Completion Date: | November 2003 |
Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
clarithromycin 250 mg tablets of Ranbaxy Laboratories
|
Drug: clarithromycin 250 mg tablets |
2: Active Comparator
Biaxin 250 mg tablets
|
Drug: clarithromycin 250 mg tablets |
This was an open label, balanced, and randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study planned on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study. Both periods were separated by a washout of twelve days The study was conducted on 32 healthy, adult, human subjects under fasting conditions. 31 subjects completed both the periods of the study
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or~ Is postmenopausal for at least 1 year; or Is surgically sterile bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif monif ) |
Study ID Numbers: | 020/CLARI-250/03 |
Study First Received: | October 15, 2008 |
Last Updated: | October 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00774189 |
Health Authority: | India: Drugs Controller General of India |
Bioequivalence clarithromycin 250mg tablets fasting |
Clarithromycin Healthy |
Anti-Infective Agents Anti-Bacterial Agents Protein Synthesis Inhibitors Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |