NCT00778583

Bioequivalence Study of Nitrofurantoin 100 mg Capsules Under Fed Conditions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Ranbaxy Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nitrofurantoin 100 mg capsules

Timeline

• Start date: 2003-09-01
• Primary completion: 2003-10-01
• Completion: 2003-12-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: India