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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 is a Phase 1 study that has completed, run by Mylan Pharmaceuticals. The registered enrollment target is 80 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01018342
The ClinicalTrials.gov registry entry for NCT01018342 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mylan Pharmaceuticals, which has 146 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg is the first listed.
NCT01018342 reports 0 study locations.
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.
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