Food Study of Nitrofurantoin Macrocrystals 100 mg Capsules and Macrodantin® 100 mg
Information source: Mylan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Nitrofurantoin Macrocrystals 100 mg Capsules (Drug); Macrodantin® 100 mg Capsules (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Mylan Pharmaceuticals Official(s) and/or principal investigator(s):
Thomas S Clark, M.D., Principal Investigator, Affiliation: Kendle International Inc.
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.
Clinical Details
Official title: Single-Dose Food In Relative Bioavailability Study of Mylan Nitrofurantoin Macrocrystals 100 mg Capsules and Procter & Gamble Macrodantin® 100 mg Capsules in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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: Hormonal contraceptives are 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 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).
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 within 1 year of the initial dose of study
medication.
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 within 30 days of
the initial dose of study medication.
3. Use of hormonal contraceptives or hormonal replacement therapy within 3 months
of the initial dose of study medication.
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.
10. Use of antacids containing magnesium trisilicate within 2 days of dosing.
Locations and Contacts
Kendle International Inc., Morgantown, West Virginia 26505, United States
Additional Information
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 FDA Enforcement Report Index Medwatch, FDA Safety Information and Adverse Event Reporting Program
Starting date: September 2003
Last updated: March 31, 2008
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