NCT01018342

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 23, 2009

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

November 19, 2009

Last Update Submit

April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg

2

ACTIVE COMPARATOR

Macrobid® Capsules 100 mg

Drug: Macrobid® Capsules 100 mg

Interventions

Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mgDRUG
1
Macrobid® Capsules 100 mgDRUG
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

MeSH Terms

Interventions

Nitrofurantoin

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Thomas S Clark, M.D.

    Kendle International Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2009

First Posted

November 23, 2009

Study Start

July 1, 2002

Primary Completion

August 1, 2002

Last Updated

April 23, 2024

Record last verified: 2024-04

Locations

US(1)