NCT00649506

CompletedPhase 1

Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules a...

Mylan Pharmaceuticals Inc Source

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Other study identifiers

Sponsor study identifier

NITF-0324

Study Type

interventional

Actual enrollment (reported)

28

Locations

1 country

Sites

1

Timeline

Study Start

September 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2003

Actual (reported)

Study Completion

September 2003

Actual (reported)

Brief Summary

The objective of this study was to evaluate the relative bioavailability of Mylan's nitrofurantoin macrocrystals 100 mg capsules to Procter \& Gamble's Macrodantin® 100 mg capsules following a single, oral 100 mg (1 x 100 mg) dose in 28 healthy, adult, non-tobacco using volunteers under fed conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 28 participants
Study completion date: September 2003
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2003
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
September 2003
Actual (reported)
Study Completion
September 2003
Actual (reported)
First Submitted
March 30, 2008
Actual (reported)
First Posted
April 1, 2008
Actual (reported)

Last Updated: April 24, 2024
Status Verified: April 2024
Last Update Submitted: April 22, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

Bioequivalence
within 30 days

Study Arms (2)

1

EXPERIMENTAL

Nitrofurantoin Macrocrystals 100 mg Capsules

Drug: Nitrofurantoin Macrocrystals 100 mg Capsules

2

ACTIVE COMPARATOR

Macrodantin® 100 mg Capsules

Drug: Macrodantin® 100 mg Capsules

Interventions

Nitrofurantoin Macrocrystals 100 mg CapsulesDrug

100mg, single dose fed

1

Macrodantin® 100 mg CapsulesDrug

100mg, single dose fed

2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age: 18 years and older.
Sex: Male and/or non-pregnant, non-lactating female

Sponsors & Collaborators

Mylan Pharmaceuticals Inc
Industrylead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

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

Enrollment

28 participants (actual enrollment reported by the registry).

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

March 30, 2008

First Posted

April 1, 2008

Study Start

September 2003

Date type not reported

This date has not been verified as actual or estimated.

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Women of childbearing potential must have negative serum Beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta-HCG) pregnancy test will be performed upon completion of the study.

Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:

intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or

barrier methods containing or used in conjunction with a spermicidal agent, or

postmenopausal or surgical sterility accompanied with a documented postmenopausal course of at least one year (tubal ligation, oophorectomy or hysterectomy).

Note: Hormonal contraceptives are NOT an acceptable form of contraception in this study.

During the course of the study, from study screen until study exit - including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method. This advice should be documented in the informed consent form.

Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiate screen, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

You may not qualify if:

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products within 1 year of the initial dose of study medication.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.
A positive test for any drug included in the urine drug screen.
Medications:
Use of any medication within the 14 days prior to the initial dose of study medication.
Use of any medication known to alter hepatic enzyme activity within 30 days of the initial dose of study medication.
Use of hormonal contraceptives or hormonal replacement therapy within 3 months of the initial dose of study medication.
Diseases:
History of any significant chronic disease.
History of drug and/or alcohol abuse.
Acute illness at the time of either the pre-study medical evaluation or dosing.
+9 more criteria

Contact the study team to confirm eligibility.

Primary Completion

September 2003

Actual (reported)

Study Completion

September 2003

Actual (reported)

Last Updated

April 24, 2024

Record last verified: 2024-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00649506
Data provider: ClinicalTrials.gov
Source updated: 2024-04-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:25:51 UTC

Locations

US(1)

Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Links

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations