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.
Full Title of Study: “Single-Dose Food In Vivo Bioequivalence Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: August 2002
- Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
- Drug: Macrobid® Capsules 100 mg
Arms, Groups and Cohorts
- Experimental: 1
- Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
- Active Comparator: 2
- Macrobid® Capsules 100 mg
Clinical Trial Outcome Measures
- The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
- Time Frame: blood collection through 28 hours
Participating in This Clinical Trial
- healthy, adult subjects, 18 years and older
- able to swallow medication
- institutionalized subjects
- history of any significant disease
- use of any prescription or OTC medications within 14 days of start of study
- received any investigational products within 30 days prior to start of study
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Mylan Pharmaceuticals
- Provider of Information About this Clinical Study
- Wayne Talton, Mylan Inc.
- Overall Official(s)
- Thomas S Clark, M.D., Principal Investigator, Kendle International Inc.
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