Overview

Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mg

Status:
Completed
Trial end date:
2002-12-01
Target enrollment:
0
Participant gender:
All
Summary
"The objective of this study was to investigate the bioequivalence of Mylan cetirizine HCl 10 mg tablets to Pfizer's Zyrtec® 10 mg tablets following a single, oral 10 mg (1 x 10 mg) dose administration under fasting conditions.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mylan Pharmaceuticals
Treatments:
Cetirizine
Criteria
Inclusion Criteria:

1. Age: 18 years and older.

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

1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy
tests performed within 14 days prior to the start of the study and on the evening
prior to each dose administration. 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. oral contraceptives initiated at least 3 months prior to the start of the
study and continued during the study, or

2. 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

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

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

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
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, opiates, 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 within the 48 hours prior to the initial dose of the
study medication.

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

3. Medications:

1. Use of any medication within the 14 days prior to the initial dose of study
medication, excluding hormonal contraceptives and hormonal replacement therapy
initiated at least 3 months prior to study medication dosing.

2. Use of any medication known to alter hepatic enzyme activity within 28 days prior
to the initial dose of study medication, excluding hormonal contraceptives and
hormonal replacement therapy initiated at least 3 months prior to study
medication dosing.

4. Diseases:

1. History of any significant chronic disease and/or hepatitis.

2. History of drug and/or alcohol abuse.

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

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 cetirizine, any of the inactive ingredients, or other
related products.

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
administration.