A Randomized, Open-label, Single-Dose, 2-Treatment, 2-Way, 2-Period Crossover Study to Assess the Safety and the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration versus time curve (AUC)
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults. Additionally the safety and tolerability of two drugs will be evaluated.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male in the age of 20-45
- •Body weight ≥ 55kg, IBW ± 20%
- •Subject who sign on an informed consent form willingly
排除标准
- •Subject with serious active cardiovascular, respiratory, hepatologic, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •Subject with known for hypersensitivity reaction to S-amlodipine, amlodipine and olmesartan and dihydropyridine derivatives
- •Clinically significant hypotension (SBP≤100mmHg, DBP≤60mmHg) or hypertension(SBP≥150mmHg, DBP≥95mmHg) when screening period
- •Subject with known for history of disease or gastric surgery which affect on the absorption,
- •Subject with any of the following conditions in laboratory test
- •AST or ALT > UNL (upper normal limit) x 1.5
- •Total bilirubin > UNL x 1.5
- •Renal failure with CLcr < 50mL/min calculated on Cockcroft-Gault [Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 *Cr)]
- •Serum potassium < 3.5 mEq/L or > 5.5 mEq/L
- •Continued excessive use of caffeine (caffeine >five cups/day), alcohol(alcohol>30g/day) and severe heavy smoker(cigarette >10 cigarettes per day)
- •Participation in any clinical investigation within 60days prior to study medication dosing
- •Subject with whole blood donation within 60days, component blood donation within 30days prior to study medication dosing
- •Subject taking inducer or inhibitor of drug metabolism enzyme such as barbital within 28days prior to study medication dosing
- •Use of any prescription medication including oriental medication within 14 days prior to study medication dosing or over-the-counter medication within 7 days prior to study medication dosing
- •Subject with mental illness or drug addiction
- •Subject taking foods which affect on the absorption, distribution, metabolism or excretion of drug within 7days prior to study medication dosing
- •Subject with decision of nonparticipation through investigator's review due to laboratory test results or other excuse such as non-responding to request or instruction by investigator
研究组 & 干预措施
T-R
First period: administration of test drug, Second period: administration of reference drug
干预措施: Sevikar tab. 10/40mg (Drug)
R-T
First period: administration of reference drug, Second period: administration of test drug
干预措施: Sevikar tab. 10/40mg (Drug)
R-T
First period: administration of reference drug, Second period: administration of test drug
干预措施: Lodivikar tab. 5/40mg (Drug)
T-R
First period: administration of test drug, Second period: administration of reference drug
干预措施: Lodivikar tab. 5/40mg (Drug)
结局指标
主要结局
Area under the plasma concentration versus time curve (AUC)
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
Peak Plasma Concentration (Cmax)
时间窗: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144hr(19 points)
次要结局
- Number of participants with adverse events(From study medication dosing day to follow-up period for maximum 7 days from the second period discharge)