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

NCT01018342 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-04-23

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

DRUG

Macrobid® Capsules 100 mg

Sponsors & Collaborators

  • Mylan Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Thomas S Clark, M.D. · Kendle International Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2002-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018342 on ClinicalTrials.gov