NCT00649285

Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

Single-Dose Food In Vivo Bioequivalence Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Mylan Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg	100mg, single dose fed
DRUG	Macrobid® Capsules 100 mg	100mg, single dose fed

Timeline

• Start date: 2002-10-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2008-04-01
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States