NCT01712126已完成不适用
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Irbesartan / Hydrochlorothiazide 300/25 mg Tablets Under Fed Conditions
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- bioequivalence determined by statistical comparison Cmax
研究概览
简要总结
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects between the ages of 18 and 45 years (inclusive).
- •Voluntary consent to participate in the study.
- •Body Mass Index (BMI) between 18 and 30 (inclusive).
- •Female subjects of childbearing potential - not surgically sterile or at least 2 years postmenopausal - must agree to utilize one of the following forms of contraception from screening through completion of the study: abstinence, hormonal (oral, implant, transdermal, or injection) for at least 3 months prior to the first dose of the study, barrier (condom with spermicide, diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
- •No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.
排除标准
- •A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •A history of allergic or adverse responses to irbesartan and hydrochlorothiazide, or any comparable or similar product.
- •Subjects who (for whatever reason) have been on an abnormal diet or have had substantial changes in eating habits within 30 days prior to study initiation.
- •Subjects must not have made a blood donation of one pint or more within 30 days prior to study initiation.
- •Subjects must not have made a plasma donation within 14 days of study initiation.
- •Participation in a clinical trial within 30 days prior to study initiation.
- •Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study.
- •Use of any prescription medication within 7 days prior to or during the study, with the exception of hormonal contraceptives for women of childbearing potential, or hormone replacement therapy.
- •Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI, antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study.
- •Smoking or use of tobacco products within 6 months prior to or during the study.
- •Female subjects who are lactating.
- •Positive serum pregnancy test for female subjects.
- •Positive blood screen for HIV, Hepatitis B or Hepatitis C.
- •Positive screen for alcohol or drugs of abuse, and history or presence of alcoholism or drug abuse within 6 months prior to the study start.
研究组 & 干预措施
Irbesartan and Hydrochlorothiazide
Experimental
300 mg and 25 mg tablet
干预措施: Irbesartan and Hydrochlorothiazide (Drug)
Avalide
Active Comparator
irbesartan 300 mg and hydrochlorothiazide 25 mg
干预措施: Avalide (Drug)
结局指标
主要结局
bioequivalence determined by statistical comparison Cmax
时间窗: Blood samples will be collected in Vacutainers containing K3EDTA (1 x 7 mL) before dose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 3, 4, 6, 8, 12, 18, 24, 36, 48, and 72 hours after dosing.
次要结局
未报告次要终点
研究者
研究点 (1)
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