An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers

Boryung Pharmaceutical Co., Ltd1 个研究点分布在 1 个国家目标入组 86 人开始时间: 2014年7月最近更新: 2014年10月15日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boryung Pharmaceutical Co., Ltd
入组人数: 86
试验地点: 1
主要终点: (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

An Open-label, Randomized, Single-dose, 2×2 Crossover Study to Compare the Pharmacokinetics of Fimasartan/Amlodipine Combination Tablet and Coadministration of Fimasartan and Amlodipine as Individual Tablets in Healthy Male Volunteers

详细描述

After subjects have signed informed consent voluntarily, they go through screening period for within 21 days.

As period I, subjects of A Group take fimasartan and amlodipine at 1st day and subjects of B Group take fimasartan/amlodipine combination at 1st day.

And then, after wash out for 14 days, as period II, subjects of A Group take fimasartan/amlodipine combination at 15th day and subjects of B Group take fimasartan and amlodipine at 15th day.

At each period, subjects of A Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

At each period, subjects of B Group have blood sampling 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hour after medication(18 times in each period, 36 times in total).

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: 19 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Healthy male subject, aged 19- 50 years at screening.
•Body weight of ≥ 50 kg and within ± 20% of ideal body weight (IBW)(kg) = {height (cm) - 100} * 0.9
•Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent

排除标准

•History of gastrointestinal disease (i.g., Crohn's disease, active peptic ulcer) or resection operation that may affect the absorption of the study drug (excluding simple appendectomy or herniorrhaphy)
•History of clinically significant hypersensitivity to study drug, any other drug or additives (yellow no.4).
•Subject that is judged inappropriate for participating in the study based on physical examination
•The levels of ALT(Aspartate Transaminase), AST (Alanin Transaminase) or total bilirubin > 1.5 x the upper limit of normal or eGFR < 60 mL/min/1.73m (calculated by MDRD)
•Evidence of hereditary disease, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
•systolic ≥ 140 mmHg or ≤ 100 mmHg, diastolic ≥ 90 mmHg or ≤ 65 mmHg), measured after taking a rest for 5minutes
•Take any other study's investigational products within 90 days prior to the first administration of study drug
•Donation of whole blood within 60 days prior to the first administration of study drug, or donation of any blood products within 30 days prior to the first administration of study drug
•Intake food like Grapefruit juice (*e.g., Grapefruit juice ≥ 1L /day) within 7 days prior to administration of study drug
•Use of any prescribed drugs or herbal remedies within 14 days, or use of any over-the-counter medication or vitamins within 7 days prior to the first administration of study drug
•Positive serologic tests (HBsAg, HCV Ab, HIV Ag/Ab, VDRL)
•Subject that is judged inappropriate for participating in the study by an investigator, based any other reason