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

This study has been completed.
Sponsor:
Information provided by:
Mylan Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01018342
First received: November 19, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
Drug: Macrobid® Capsules 100 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.

Resource links provided by NLM:


Further study details as provided by Mylan Pharmaceuticals:

Primary 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: July 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
Active Comparator: 2
Macrobid® Capsules 100 mg
Drug: Macrobid® Capsules 100 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018342

Locations
United States, West Virginia
Kendle International Inc.
Morgantown, West Virginia, United States, 26505
Sponsors and Collaborators
Mylan Pharmaceuticals
Investigators
Principal Investigator: Thomas S Clark, M.D. Kendle International Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT01018342     History of Changes
Other Study ID Numbers: NITF-0256
Study First Received: November 19, 2009
Last Updated: November 19, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on April 21, 2014