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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Group Type EXPERIMENTAL

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Intervention Type DRUG

2

Macrobid® Capsules 100 mg

Group Type ACTIVE_COMPARATOR

Macrobid® Capsules 100 mg

Intervention Type DRUG

Interventions

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Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Intervention Type DRUG

Macrobid® Capsules 100 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes