A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic Drug Interaction of LC15-0444 and Pioglitazone After Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone
研究概览
简要总结
The objective of the study is to investigate the drug interaction between LC15-0444 and pioglitazone by comparing the safety, tolerability and pharmacokinetics of LC15-0444 and pioglitazone are administered concomitantly and each alone in healthy male subjects.
详细描述
This study is a randomized, open-label, three-treatment, three-period, three-sequence and crossover design in healthy volunteers to evaluate tolerability, safety and pharmacokinetics after the multiple administration of LC15-0444 and pioglitazone concomitantly or each alone.
Eligibility for participation of this study will be determined by demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks(-21 d ~ -2 d) before drug administration(1 d). Eligible subjects will be randomized to one of three sequence groups.
According to the characteristics of anti-diabetic drugs, it is expected to be administered with other anti-diabetic drugs. Therefore, Drug-Drug Interaction with Pioglitazone should be identified in this trial.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 20 and 45 years at screening
- •Subjects with Body Mass Index (BMI) between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive). BMI(kg/m2) = body weight(kg)/{height(m)}
- •Subjects with fasting plasma glucose (FPG) level of 70-125 mg/dL (both inclusive) at the time of screening.
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
排除标准
- •Subjects with evidence or history of clinically significant hepatic (including carrier of viral hepatitis), renal, neurologic (mood disorder, obsessive-compulsive disorder etc.), immunologic, pulmonary, endocrine, hematological, neoplastic, cardiovascular or psychiatric disease.
- •Subjects with evidence or history of gastrointestinal disease (Crohn's disease, ulcer, acute or chronic pancreatitis etc.) or surgery (except appendectomy and herniotomy) possibly affecting drug absorption.
- •Subjects with history of hypersensitivities including drug allergies (caused by aspirin, antibiotics, etc.), or history of clinically significant hypersensitivities.
- •Subjects who meet the following criteria at the time of the screening examination; Serum AST(SGOT) or ALT(SGPT): > 1.5 times upper normal limit Creatinine clearance calculated by Cockcroft-Gault equation
- •< 80 mL/min Clinical significant abnormalities on ECG including 12-lead ECG demonstrating QTc >450 msec at screening or any rhythms except for sinus rhythm
- •Subjects who show the following vital sign results at sitting position after resting for 3 min; SBP: ≤ 100 mmHg or ≥ 150 mmHg DBP: ≤ 60 mmHg or ≥ 95 mmHg
- •Subjects with history of drug abuse or a positive urine result in drug screen for drug abuse or cotinine.
- •Subjects who have taken any prescribed medicines or herbal medicines within 2 weeks before the first administration of the investigational product, any non-prescribed medicines or vitamin supplements within 1 week before the first administration of the investigational product. (If other conditions are satisfied, subjects may be eligible for the trial by the investigator's judgment.)
- •Subjects who have participated in any other clinical trial within 2 months before the first administration of the investigational product.
- •Subjects who have donated a unit of blood within 2 months or blood components within 1 month before the first administration of the investigational product.
- •Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or unable to abstain from drinking throughout the trial.
- •Smokers (except for those who quit smoking for at least 3 months the first administration of the investigational product)
- •Subjects who take caffeine-containing or grapefruit-containing products within 3 days before the first administration of the investigational product.
研究组 & 干预措施
LC15-0444 200 mg
LC15-0444 200 mg
干预措施: LC15-0444, Pioglitazone (Drug)
Pioglitazone 30 mg
Pioglitazone 30 mg
干预措施: LC15-0444, Pioglitazone (Drug)
LC15-0444 200 mg + pioglitazone 30 mg
LC15-0444 200 mg + pioglitazone 30 mg
干预措施: LC15-0444, Pioglitazone (Drug)
结局指标
主要结局
AUCτ,ss, Cmax,ss of LC15-0444 and pioglitazone
时间窗: During all dosing visits
次要结局
- Tmax,ss, t1/2, CL/F, Aeτ,ss, CLR, Ctrough,ss of LC15-0444 and pioglitazone AUCτ,ss, Cmax,ss, metabolic ratio of LC15-0444, Pioglitazone metabolites AUC,ss, Cmax,ss, metabolic ratio of pioglitazone metabolites(During all dosing visits)