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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00649285
The ClinicalTrials.gov registry entry for NCT00649285 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (89% lower). The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.