Status:
COMPLETED
Food Study of Cetirizine HCl Tablets 10 mg and Zyrtec® 10 mg
Lead Sponsor:
Mylan Pharmaceuticals Inc
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this study was to investigate the bioequivalence of Mylan's cetirizine HCl tablets to Pfizer's Zyrtec® tablets following a single, oral 10 mg (1 x 10 mg) dose administered under fed c...
Eligibility Criteria
Inclusion
- Age: 18 years and older.
- Sex: Male and 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 the start of the study and the evening prior to dosing of each study period. An additional 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:
- hormonal contraceptives initiated at least 3 months prior to the start of the study and continued during the study, or
- 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).
- 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.
- Women are allowed to be taking hormone replacement therapy provided that the dosage regimen was initiated at least 3 months prior to the start of the study and continued from study screen until study exit.
- 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 ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- 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, cannabinoids, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.
Exclusion
- 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.
- Medications:
- Use of any medication within the 14 days prior to the initial dose of study medication, excluding hormonal contraceptives and replacement therapy initiated at least 3 months prior to study medication dosing.
- 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 replacement therapy initiated at least 3 months prior to study medication dosing.
- Diseases:
- History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic disease.
- History of drug and/or alcohol abuse.
- Acute illness at the time of either the pre-study medical evaluation or dosing.
- Abnormal and clinically significant laboratory test results:
- Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
- Abnormal and clinically relevant ECG tracing.
- Donation or loss of a significant volume of blood or plasma (\> 450 mL) within 28 days prior to the initial dose of study medication.
- Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- Allergy or hypersensitivity to cetirizine, any of the inactive ingredients, or other related products.
- History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
- Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2002
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00649857
Start Date
November 1 2002
End Date
December 1 2002
Last Update
April 24 2024
Active Locations (1)
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1
Novum Pharmaceutical Research Services
Houston, Texas, United States, 77042