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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01018342

Enrollment

Registered

2009-11-23

Start date

2002-07-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGNitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

DRUGMacrobid® Capsules 100 mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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.	blood collection through 28 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026