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

Mylan

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Macrobid® Capsules 100 mg; Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018342

NITF-0256

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

1

Experimental group

Description:

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Treatment:

Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

2

Active Comparator group

Description:

Macrobid® Capsules 100 mg

Treatment:

Drug: Macrobid® Capsules 100 mg