NCT00649857已完成1 期
Single-Dose Food In Vivo Bioequivalence Study of Cetirizine HCl Tablets (10 mg; Mylan) and Zyrtec® (10 mg; Pfizer) in Healthy Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
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 conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
1
Experimental
Cetirizine HCl Tablets 10 mg
干预措施: Cetirizine HCl Tablets 10 mg (Drug)
2
Active Comparator
Zyrtec® 10 mg
干预措施: Zyrtec® 10 mg (Drug)
结局指标
主要结局
Bioequivalence
时间窗: within 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Fasting Study of Cetirizine HCl Tablets 10 mg and Zyrtec® Tablets 10 mgHealthyNCT00650065Mylan Pharmaceuticals Inc26
已完成
1 期
Fed Study of Carvedilol Tablets 12.5 mg to Coreg® Tablets 12.5 mgHealthyNCT00648622Mylan Pharmaceuticals Inc50
已完成
1 期
Food Study of Ciprofloxacin Extended-Release Tablets 1000 mg and Cipro® XR Tablets 1000 mgHealthyNCT00650351Mylan Pharmaceuticals Inc35
已完成
1 期
Food Study of Clopidogrel Bisulfate Tablets 75 mg to Plavix® Tablets 75 mgHealthyNCT00650169Mylan Pharmaceuticals Inc47
已完成
1 期
Food Study of Pioglitazone HCl Tablets 45 mg to Actos® Tablets 45 mgHealthyNCT00649012Mylan Pharmaceuticals Inc40