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.

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Crossover Assignment, Bio-equivalence Study

Study Primary Completion Date: August 2002

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 Sponsor: Mylan Pharmaceuticals

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 04, 2010

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

Mylan Pharmaceuticals Inc. - Clinical Trial Results

Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use

Recalls, Market Withdrawals and Safety Alerts

FDA Enforcement Report Index

Medwatch, FDA Safety Information and Adverse Event Reporting Program