Clinical Trial to Investigate the Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet in Healthy Male Subjects : An Open, Parallel Dose Group Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.
研究概览
简要总结
The purposes of this study are to investigate the duration of P-glycoprotein inhibition after oral administration of HM30181AK tablet in healthy male subject and proper dose of HM30181AK tablet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged 20 to 50 years at screening
- •Subjects whose weights are heavier than or equal to 50 kg and ±20% of ideal body weight
- •Ideal body weight = (height cm - 100) x 0.9
- •Subjects who provided written, voluntary informed consent to participate in this clinical trial and to comply the directions including contraception after being fully informed of and understand this trial
排除标准
- •Subjects who have the clinically significant diseases or history in liver, kidney, nervous system, respiratory system, endocrine system, blood tumor and cardiovascular system.
- •History of the gastrointestinal diseases which may affect the absorption of oral drugs (e.g., Crohn's disease) or gastrointestinal operations (excluding simple typhlotomy and hernia repair).
- •The following results in laboratory test
- •AST, ALT > 1.25 x upper limits of normal
- •Systolic blood pressure below 100 mmHg or above 150 mmHg or diastolic blood pressure below 65 mmHg or above 95 mmHg in vital signs
- •History of drug allergy or other allergies which are clinically significant
- •History of drug abuse or positive reaction for drug abuse in urine screening test
- •Subjects who took prescription drugs or herbal medicines within 2 weeks prior to the first day of drug administration or OTC or vitamin preparations within 1 week prior to the first day of drug administration If the subjects meet other criteria, they could participate in the trial in the judgement of investigator.)
- •Subjects who have participated in other clinical trial within 2 months prior to the first day of drug administration
- •Whole blood donation within 2 months prior to the first day of drug administration or apheresis donation within 2 weeks prior to the first day of drug administration
- •Subject who are continuously drinking alcohol (over 21 units/week) or who cannot quit drinking during clinical trial period
- •Subject who are smoking over 10 cigar/day
- •Subjects who eat food containing caffeine or grapefruit or drink alcohol in prohibited period
- •Subjects who are inappropriate in the judgement of the investigator due to the reasons including clinical laboratory test results
研究组 & 干预措施
1mg group
Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: HM30181AK 1mg (Drug)
1mg group
Administration of HM30181AK 1mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: Loperamide 2mg (Drug)
5mg group
Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: HM30181AK 5mg (Drug)
5mg group
Administration of HM30181AK 5mg on day 4 and Loperamide 16mg(Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: Loperamide 2mg (Drug)
10mg group
Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: HM30181AK 5mg (Drug)
10mg group
Administration of HM30181AK 10mg(HM30181AK 5mg x 2tab)on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: Loperamide 2mg (Drug)
15mg group
Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: HM30181AK 15mg (Drug)
15mg group
Administration of HM30181AK 15mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: Loperamide 2mg (Drug)
60mg group
Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: HM30181AK 60mg (Drug)
60mg group
Administration of HM30181AK 60mg on day 4 and Loperamide 16mg (Loperamide 2mg x 8cap) on day 1,4,8,11,15
干预措施: Loperamide 2mg (Drug)
结局指标
主要结局
Evaluate the duration of P-glycoprotein inhibition of HM30181AK by the Loperamide AUC measurement.
时间窗: Day 1~Day 18
次要结局
- Evaluate the PK parameters (Cmax, AUClast, AUCinf, Tmax, T1/2, CL/F etc) of HM30181AK by measuring the blood concentration of HM30181AK(Day 4)