Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg

Official Title: “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.”

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.

Intervention(s) in this Clinical Trial

• Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
• Drug: Macrobid® Capsules 100 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
• Active Comparator: 2
  • Macrobid® Capsules 100 mg

Primary 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
    Safety Issue?: No

Inclusion Criteria:

• healthy, adult subjects, 18 years and older
• able to swallow medication

Exclusion Criteria:

• 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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Mylan Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Thomas S Clark, M.D. Principal Investigator Kendle International Inc.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01018342

Study ID Number: NITF-0256

ClinicalTrials.gov Identifier: NCT01018342

Health Authority: United States: Institutional Review Board

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