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

Overview

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.

Full Title of Study: “Single-Dose Food In Vivo Bioequivalence Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules (100 mg; Mylan) and Macrobid® Capsules (100 mg; Procter & Gamble) in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2002

Interventions

  • Drug: Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
    • 100mg, single dose fed
  • Drug: Macrobid® Capsules 100 mg
    • 100mg, single dose fed

Arms, Groups and Cohorts

  • Experimental: 1
    • Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg
  • Active Comparator: 2
    • Macrobid® Capsules 100 mg

Clinical Trial Outcome Measures

Primary Measures

  • Bioequivalence
    • Time Frame: within 30 days

Participating in This Clinical Trial

Inclusion Criteria

1. Age: 18 years and older.

2. Sex: Male and/or non-pregnant, non-lactating female

1. 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.

2. 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:

1. 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

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

3. 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.

3. 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.

3. 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).

4. 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.

Exclusion Criteria

1. Institutionalized subjects will not be used.

2. Social Habits:

1. Use of any tobacco products.

2. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.

3. Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.

4. Any recent, significant change in dietary or exercise habits.

5. A positive test for any drug included in the urine drug screen.

3. Medications:

1. Use of any medication within the 14 days prior to the initial dose of study medication.

2. Use of any medication known to alter hepatic enzyme activity including oral contraceptives or hormone replacement therapy.

4. Diseases:

1. History of any significant chronic disease.

2. History of drug and/or alcohol abuse.

3. Acute illness at the time of either the pre-study medical evaluation or dosing.

4. A positive HIV, hepatitis B, or hepatitis C test.

5. Abnormal and clinically significant laboratory test results:

1. Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).

2. Abnormal and clinically relevant ECG tracing.

6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.

7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.

8. Allergy or hypersensitivity to nitrofurantoin or other related products.

9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mylan Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Will Sullvan, Global Head of Product Risk and Safety Management, Mylan Inc.
  • Overall Official(s)
    • Thomas S Clark, M.D., Principal Investigator, Kendle International Inc.

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