Trials / Completed
CompletedNCT01018342
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
Single-Dose Food In Vivo Bioequivalence Study of Mylan 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
- 80 (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 nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg | |
| DRUG | Macrobid® Capsules 100 mg |
Timeline
- Start date
- 2002-07-01
- Primary completion
- 2002-08-01
- First posted
- 2009-11-23
- Last updated
- 2024-04-23
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01018342. Inclusion in this directory is not an endorsement.