Single Dose Two-Way Crossover Fed Bioequivalence Study of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Bioequivalence
研究概览
简要总结
The purpose of this study was to determine the bioavailability of Benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
详细描述
The study was performed as a single-dose (one 20 mg/25 mg tablet), two way crossover bioequivalence study with a wash out of 7 days between doses and with equal number of subjects randomly assigned to the sequence (AB or BA) in which they received the study Test (A) and Reference (B) treatments.
Subjects were confined in the clinical facility for at least 10 hours before dosing and for 24 hours after dosing. Subjects were discharged after 24-hours blood sample and returned as outpatients for the remaining blood samples. Standardized meals were served and no caffeine, alcohol, or grapefruit-containing foods or beverages were allowed to be consumed 24 hours before dosing or throughout study confinement.
A total of 30 subjects (20 men and 10 women) were randomized to receive single oral dose of Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg tablet and 28 subjects completed both the periods of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy Subjects at least 18 years of age..
- •Informed of the nature of the study and given written informed consent.
- •Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds.
排除标准
- •- Hypersensitivity to Benazepril (Lotensin®) or thiazide diuretics such as hydrochlorothiazide (Oretic® and Hydro Diuril®).
- •Any history of clinical condition that might affect drug absorption, metabolism or excretion.
- •Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism.
- •Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- •Received an investigational drug within the past 4 weeks prior to study dosing.
- •Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician.
- •Regular smoking of more than 5 cigarettes daily use of nicotine-containing products beginning 3 months before study medication administration through the final evaluation.
- •If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and /or her partner are: oral contraceptives, progestin injection or implant, condom with spermacide, diaphragm with spermicide, IUD, vaginal spermicide Suppository, surgical sterilization of their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
- •Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 1 day before each study medication administration through each study confinement period. Such restricted items include coffee, tea, iced tea, coke®, Pepsi®, Mountain Dew®, Chocolate, brownies, etc.
研究组 & 干预措施
1
Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets
干预措施: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets (Drug)
2
Lotensin® HCT tablets
干预措施: Benazepril HCl/ Hydrochlorothiazide 20 mg/ 25 mg Tablets (Drug)
结局指标
主要结局
Bioequivalence
次要结局
未报告次要终点