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

NCT00649285 | Completed Phase 1

• 1 other identifier: NITF-02103
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

  within 30 days

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 mg DRUG

100mg, single dose fed

1

Macrobid® Capsules 100 mg DRUG

100mg, single dose fed

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 years and older.
• Sex: Male and/or non-pregnant, non-lactating female
• 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: Oral contraceptive is 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 10% 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.
• 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 including oral contraceptives or hormone replacement therapy.
• 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.
• A positive HIV, hepatitis B, or hepatitis C test.

Sponsors & Collaborators

• Mylan Pharmaceuticals Inc: lead

Study Sites (1)

Kendle International Inc.

Morgantown, West Virginia, 26505, United States

Location

Related Links

• Mylan Pharmaceuticals Inc. - Clinical Trial Results
• Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in use
• Recalls, Market Withdrawals and Safety Alerts

MeSH Terms

Interventions

Nitrofurantoin

Intervention Hierarchy (Ancestors)

Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic 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: March 30, 2008
• First Posted: April 1, 2008
• Study Start: October 1, 2002
• Primary Completion: November 1, 2002
• Study Completion: November 1, 2002
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

US (1)