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

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ClinicalTrials.gov Identifier: NCT01018342
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Mylan Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg Drug: Macrobid® Capsules 100 mg Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : July 2002
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Additional Information:
Responsible Party: Wayne Talton, Mylan Inc.
ClinicalTrials.gov Identifier: NCT01018342     History of Changes
Other Study ID Numbers: NITF-0256
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Nitrofurantoin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents