An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic Interactions Between HL237 and Tacrolimus in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Peak plasma concentration at steady state(Cmax,ss) of HL237
研究概览
简要总结
This study aims to evaluate the pharmacokinetic interaction between HL237 and tacrolimus in healthy male subjects.
详细描述
To evaluate the pharmacokinetic interaction by comparing of pharmacokinetic parameters when administered HL237(or tacrolimus) between with tacrolimus(or HL237) and without tacrolimus(or HL237).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male, 19 years ≤ age ≤ 45
- •Body weight ≥ 50kg and 18.5 ≤ BMI ≤ 29.9kg/m2
- •Subjects are agree to use contraceptives that protocol suggest and not provide sperm for up to 2 months after the last administration of the investigational drug
- •Volunteer
排除标准
- •Subject with serious cardiovascular, respiratory, hepatology, renal, hematologic, gastrointestinal, immunologic, dermal, neurologic, or psychological disease or history of such disease
- •Subject with symptoms of acute disease within 28 days prior to investigational products dosing
- •Subject with medical history which able to affect absorption, distribution, metabolism and excretion of drug
- •Subject with hypersensitive reaction to following drug or history of clinically significant hypersensitive reaction to following drug
- •Calcineurin inhibitor or Macrolides
- •Subject with clinically significant active chronic disease
- •Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucosegalactose malabsorption
- •Subjects who showed one or more of the following in a screening test including a retest
- •AST, ALT > UNL (upper normal limit) x 2.5
- •Creatinine clearance =< 80mL/min (Cockcroft-Gault GFR = (140-age) * (Wt in kg) / (72 * Cr))
- •Results of ECG, QTc > 450 msec
- •Positive test results for hepatitis B virus surface antigen, anti-hepatitis C virus antibody, anti-Human Immunodeficiency virus antibody or venereal disease research laboratory test
- •Use of any prescription medication within 14 days prior to study medication dosing
- •Use of any over-the-counter(OTC) medication within 7 days prior to study medication dosing
- •Subject with clinically significant allergic disease (except for mild allergic rhinitis and mild allergic dermatitis that are not needed to administer drug)
- •Subject who is not able to taking standard meals provided by the institution
- •Subject with whole blood donation within 60 days, component blood donation within 20 days
- •Subjects receiving blood transfusion within 30 days prior to study medication dosing
- •Participation in any clinical investigation within 6 months prior to study medication dosing
- •Use of any medication effected on drug enzyme induction or inhibition such as barbitals within 30 days prior to study medication dosing
- •Subjects who have continuously consumed grapefruit juice or caffeine (grapefruit juice or caffeine > 5 cups/day), or who can't refrain from intake during hospitalization
- •Subjects who have continued to drink alcohol (alcohol> 30 g/day) or who can't quit drinking during hospitalization
- •Severe heavy smoker(cigarette > 10 cigarettes per day) or subjects who can't quit smoking during hospitalization
- •Subjects that the investigator deems unsuitable for participation in the clinical trial 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
Single arm
This single arm is conducted in fixed-sequence(Treatment A ->(washout period) -> Treatment B -> Treatment C -> Maintenance treatment).
Treatment A : tacrolimus 5mg po single dose, Treatment B : HL237 400mg bid for 4 days, Treatment C: tacrolimus 5mg po single dose and HL237 400 mg bid, Maintenance treatment : HL237 400mg bid for 2 days
干预措施: HL237 tablet (Drug)
Single arm
This single arm is conducted in fixed-sequence(Treatment A ->(washout period) -> Treatment B -> Treatment C -> Maintenance treatment).
Treatment A : tacrolimus 5mg po single dose, Treatment B : HL237 400mg bid for 4 days, Treatment C: tacrolimus 5mg po single dose and HL237 400 mg bid, Maintenance treatment : HL237 400mg bid for 2 days
干预措施: tacrolimus capsule (Drug)
结局指标
主要结局
Peak plasma concentration at steady state(Cmax,ss) of HL237
时间窗: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Peak whole-blood concentration(Cmax) of tacrolimus
时间窗: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Area under the plasma concentration versus time curve during a dosage interval(AUCτ) of HL237
时间窗: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour(after dosing) on day 21 and day 22
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
Area under the whole-blood concentration versus time curve from time zero to time of last measurable concentration(AUClast) of tacrolimus
时间窗: 0(before dosing), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72hour(after dosing) on day 1 and day 22
Comparison of pharmacokinetic parameters between when administered tacrolimus with HL237 and without HL237
次要结局
未报告次要终点