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NCT00649285 · ClinicalTrials.gov registry record · Phase 1
Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
A Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT00649285: Completed Phase 1 study of Healthy, sponsored by Mylan Pharmaceuticals.
NCT00649285 is a Phase 1 study of Healthy that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 71 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00649285, a Phase 1 study of Healthy, has completed, sponsored by Mylan Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
- DRUG Macrobid® Capsules 100 mg
Study Locations (1)
West Virginia
- Kendle International Inc. - Morgantown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2002-10 |
| Est. Completion | 2002-11 |
| Phase | Phase 1 |
What the finished NCT00649285 record still lists
NCT00649285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg is the first listed.
NCT00649285 reports a single indexed study location in West Virginia.
Frequently Asked Questions
What is clinical trial NCT00649285 about?
NCT00649285 is a clinical study titled "Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg". 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.
What is the current status of trial NCT00649285?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2002-10. Estimated completion is 2002-11.
What conditions does trial NCT00649285 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT00649285?
The interventions under investigation include: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg (DRUG), Macrobid® Capsules 100 mg (DRUG).
Who is sponsoring clinical trial NCT00649285?
This trial is sponsored by Mylan Pharmaceuticals, which has 146 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00649285 being conducted?
This trial has 1 study location across West Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00649285's enrollment target sits among peer trials
71 322nd of 1090 higher than 767 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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.
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