An Open-label, Randomized, Multiple-dose, Replicated Crossover Study to Evaluate Drug-drug Interaction Following Co-administration of Tegoprazan or RAPA114 With Atorvastatin in Healthy Adults
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
- AUCτ of atorvastatin
研究概览
简要总结
This study aims to evaluate the influence of tegoprazan or RAPA114 on the Pharmacokinetic characteristics of atorvastatin following co-administration of tegoprazan or RAPA114 in healthy adult volunteers.
详细描述
[Pharmacokinetic Assessments] : Blood concentration of atorvastatin, 2-OH atorvastatin
- Primary outcome: AUCτ, Css,max of atorvastatin
- Secondary outcome: Tss,max of atorvastatin, AUCτ, Css,max of 2-OH atorvastatin, metabolic ratio
[Sefety Assessments]
: Safety assessments with adverse event monitoring including subjective/objective symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged 19 to 55 years (inclusive) at the time of his consent.
- •Body mass index (BMI) ≥ 19.0 and ≤ 27.0 kg/m2 at screening.
- •Decides to participate voluntarily in the trial after being fully informed of and understanding the study completely, and provides the written informed consent to participate in the trial and to comply with the trial-specific requirements.
- •Has the ability and willingness to participate in the entire period of clinical trial.
排除标准
- •A subject with clinically significant disease or history of hepatobiliary, renal, gastrointestinal, cardiovascular, musculoskeletal, endocrine, respiratory, neuropsychiatry or hemato-oncologic system, etc.
- •A subject with a history of hypersensitivity reactions to main constituents of or identical affiliation of the investigational products (ex, HMG-CoA reductase inhibitor, gastric acid suppressants), or have allergic diseases that require treatment.
- •A subject with a history of genetic myopathy or family history.
- •A subject who has participated in other clinical trials and received the investigational products within 180 days prior to the randomization.
- •A subject who received any medications or foods that could significantly affect the absorption, distribution, metabolism, or excretion of an investigational product within 30 days prior to the randomization.
- •A subject with history of whole blood donation within 60 days, or with blood components or received transfusion within 30 days prior to the randomization.
- •A subject with continued consumption of alcohol more than 140 g per week.
- •A subject with AST, ALT, or γ-GT levels exceeding 1.5 times of the upper limit of the reference range in the screening test.
- •A subject with a calculated glomerular filtration rate of less than 60 mL / min / 1.73 m2 in the screening test.
- •A subject with any positive result on serology tests for hepatitis B, hepatitis C, HIV or syphilis in the screening test.
- •A subject with galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose malabsorption, etc.
- •Male subject who don't have willing to accept medically acceptable contraceptive methods during the course of clinical trial, or who plan to provide sperm.
- •A subject who is determined to be ineligible to participate in the clinical trial by the investigator for other reasons.
研究组 & 干预措施
Atorvastatin 40 mg
Oral administration of Atorvastatin 40 mg tablet once daily for 7 days
干预措施: Atorvastatin 40 mg (Drug)
Atorvastatin 40 mg + Tegoprazan 50 mg
Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days
干预措施: Atorvastatin 40 mg (Drug)
Atorvastatin 40 mg + Tegoprazan 50 mg
Oral administration of Atorvastatin 40 mg tablet and Tegoprazan 50 mg tablet once daily for 7 days
干预措施: Tegoprazan 50 mg (Drug)
Atorvastatin 40 mg + RAPA114
Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days
干预措施: Atorvastatin 40 mg (Drug)
Atorvastatin 40 mg + RAPA114
Oral administration of Atorvastatin 40 mg tablet and RAPA114 tablet once daily for 7 days
干预措施: RAPA114 (Drug)
结局指标
主要结局
AUCτ of atorvastatin
时间窗: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Area under the plasma drug concentration-time curve at steady state
Css,max of atorvastatin
时间窗: Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period
Maximum concentration of drug in plasma of atorvastatin at steady state
次要结局
- AUCτ of 2-OH atorvastatin(Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period)
- Css,max of 2-OH atorvastatin(Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period)
- Tss,max of atorvastatin(Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period)
- metabolic ratio(Pre-dose on Day 1,5,6,7 and post-dose up to 24 hours on Day 7 in each period)