Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg (Drug); Macrobid® Capsules 100 mg (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s): Thomas S Clark, M.D., Principal Investigator, Affiliation: Kendle International Inc.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information
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
Starting date: July 2002
Last updated: November 19, 2009
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