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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:

U.S. FDA Resources

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:
Mylan Pharmaceuticals Inc. - Clinical Trial Results  This link exits the ClinicalTrials.gov site
Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use  This link exits the ClinicalTrials.gov site
Recalls, Market Withdrawals and Safety Alerts  This link exits the ClinicalTrials.gov site
FDA Enforcement Report Index  This link exits the ClinicalTrials.gov site
Medwatch, FDA Safety Information and Adverse Event Reporting Program  This link exits the ClinicalTrials.gov site

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 June 18, 2013