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

Overview

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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2002

Interventions

  • 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

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • 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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