Fasting Study of Terbinafine Hydrochloride Tablets 250 mg and LamisilĀ® Tablets 250 mg

Trial end date:
Target enrollment:
Participant gender:
The objective of this study was to investigate the bioequivalence of Mylan's terbinafine hydrochloride 250 mg tablets to Novartis' LamisilĀ® 250 mg tablets following a single, oral 250 mg (1 x 250 mg) dose administered under fasting conditions.
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Lead Sponsor:
Mylan Pharmaceuticals
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 (beta-HCG) pregnancy tests performed within 14 days prior to the
start of the study and on the evening prior to each dose administration. If
dosing is scheduled on weekends, 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. No
hormonal contraceptives or hormone replacement therapy are permitted in this
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,

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

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 device. This advice should be documented in the informed consent

3. Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and all
subjects 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

4. All subjects should be judged normal and healthy during a pre-study medical evaluation
(physical examination, laboratory evaluation, hepatitis B and hepatitis C tests, HIV
test, 12-lead ECG, and urine drug screen including amphetamine, barbiturates,
benzodiazepines, canabinoid, 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 start of the study.

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 7 days 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.

6. History of drug and/or alcohol abuse.

3. Medications:

1. Use of any prescription or over-the-counter (OTC) medications within the 14 days
prior to the initial dose of study medication.

2. Use of any hormonal contraceptives and hormone replacement therapy within 3
months prior to study medication dosing.

3. Use of any medication known to alter hepatic enzyme activity within 28 days prior
to the initial dose of study medication.

4. Diseases:

1. History of any significant cardiovascular, hepatic, renal, pulmonary,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic

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

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

4. Chronic or active liver disease.

5. Abnormal and clinically significant laboratory test results:

1. Clinically significant deviation from the Guide to Clinically Relevant

2. Abnormal and clinically relevant ECG tracing.

3. Outside normal range AST, ALT, alkaline phosphatase, and/or total bilirubin
laboratory results.

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 terbinafine or any other related drugs.

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

10. Consumption of grapefruit or grapefruit containing products within 7 days of drug