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NCT01018342 · ClinicalTrials.gov registry record · Phase 1
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
A Phase 1 study, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
NCT01018342: Completed Phase 1 study, sponsored by Mylan Pharmaceuticals.
NCT01018342 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01018342, a Phase 1 study, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
Study 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.
Interventions
- DRUG Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
- DRUG Macrobid® Capsules 100 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2002-07 |
| Phase | Phase 1 |
What the finished NCT01018342 record still lists
NCT01018342 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% higher).
The record links to 0 conditions, and to 2 interventions - of which Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg is the first listed.
NCT01018342 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01018342 about?
NCT01018342 is a clinical study titled "Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg". 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.
What is the current status of trial NCT01018342?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2002-07.
What interventions are being tested in trial NCT01018342?
The interventions under investigation include: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg (DRUG), Macrobid® Capsules 100 mg (DRUG).
Who is sponsoring clinical trial NCT01018342?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01018342's enrollment target sits among peer trials
80 672nd of 2000 higher than 1,305 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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