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Sponsored by: |
Ranbaxy Laboratories Limited |
---|---|
Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778583 |
An open label, randomised, two-treatment, four-period, two-sequence, single-dose, crossover, fully replicated bioavailability study on Nitrofurantoin formulations comparing Nitrofurantoin 100 mg capsules of Ranbaxy Laboratories with Macrobid 100 mg capsules in healthy, adult, human subjects under fed conditions
Condition | Intervention |
---|---|
Healthy |
Drug: Nitrofurantoin 100 mg capsules |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | An Open Label, Randomised, Two-Treatment, Four-Period, Two-Sequence, Single-Dose, Crossover, Fully Replicated Bioavailability Study on Nitrofurantoin Formulations Comparing Nitrofurantoin 100 mg Capsules of Ranbaxy Laboratories With Macrobid 100 mg Capsules in Healthy, Adult, Human Subjects Under Fed Conditions |
Enrollment: | 40 |
Study Start Date: | September 2003 |
Study Completion Date: | December 2003 |
Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Nitrofurantoin 100 mg capsules of Ranbaxy
|
Drug: Nitrofurantoin 100 mg capsules |
2: Active Comparator
Macrobid 100 mg capsules
|
Drug: Nitrofurantoin 100 mg capsules |
This was an open-label, randomized, single-dose, four period fully replicate crossover, relative bioavailability study performed on 40 healthy adult male and. A total of 35 completed the clinical phase of the study.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Ranbaxy Research Laboratories ( Dr. Tausif Monif ) |
Study ID Numbers: | 024/NITRO-100/03 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778583 |
Health Authority: | India: Drugs Controller General of India |
Bioequivalence Nitrofurantoin capsules |
Malnutrition Nitrofurantoin Healthy |
Anti-Infective Agents Therapeutic Uses Anti-Infective Agents, Urinary Renal Agents Pharmacologic Actions |