Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg
Public ClinicalTrials.gov record NCT00649506. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Single-Dose Food In Relative Bioavailability Study of Mylan Nitrofurantoin Macrocrystals 100 mg Capsules and Procter & Gamble Macrodantin® 100 mg Capsules in Healthy Volunteers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study was to evaluate the relative bioavailability of Mylan's nitrofurantoin macrocrystals 100 mg capsules to Procter \& Gamble's Macrodantin® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco using volunteers under fed conditions.
Study identification
- NCT ID
- NCT00649506
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 28 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2003
- Primary completion
- Aug 31, 2003
- Completion
- Aug 31, 2003
- Last update posted
- Apr 23, 2024
2003
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kendle International Inc. | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00649506, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 23, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00649506 live on ClinicalTrials.gov.