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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01018342

Run by

Mylan Pharmaceuticals Inc

People needed

80

Starts

2002-07-01

Last updated by the study team

2024-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy, adult subjects, 18 years and older
• able to swallow medication

You may not qualify if…

• 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

Where it is running

• Kendle International Inc. — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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