A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Pharmacokinetic Characteristics of CKD-395 0.25/750 mg in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- AUClast of Lobeglitazone
研究概览
简要总结
This study is a randomized, open-label, single dose, 2-way crossover study to compare the pharmacokinetic characteristics of CKD-395 0.25/750 mg in healthy male volunteers.
详细描述
To healthy male subjects of twenty six(26), following treatments are administered dosing in each period fed condition(high fat meals) and wash-out period is a minimum of 7 days.
Treatment A(Reference Drug): DuvieTM Tab. 0.5mg 1T + Glucodaun OR Tab. 750mg 2T Treatment B(Test Drug): CKD-395 0.25/750mg Tab. 2T Pharmacokinetic blood samples are collected up to 48hrs. Safety and pharmacokinetic are assessed.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy man older than 19 years at the time of screening.
- •BMI more than 17.5kg/m2 and less than 30.5kg/m2 and weight more than 55kg
- •Subject without congenital or chronic diseases and no psychotic symptoms or findings from the medical examination.
- •Suitable subject who is determined by laboratory tests such as hematology tests,blood chemistry, urinalysis test according to the characteristics of the drug and screening tests such as ECG test.
- •Subject who fully understand the clinical trials after in-depth explanation given prior to the clinical study, decided to join the clinical trials by their will and signed consent form which approved by Chonbuk National University Hospital IRB.
- •Subjects who are able to comply with all scheduled visits, laboratory tests and other procedures.
排除标准
- •Subjects who has a history of blood, kidneys, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurological or allergic diseases that is clinically significant (Except untreated asymptomatic seasonal allergies at the time of administration)
- •Subjects who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption.
- •Subjects who show AST or AST > 2 times upper limit of normal range.
- •Subjects who drink Alcohol > 210g/week within 6 months prior to the screening.
- •Subjects who take the medication involved in other clinical trials or bioequivalence tests within three months before the first dose medication characters.
- •Subjects who show Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg at screening.
- •Subjects who have history of alcohol or drug abuse, within 1 year
- •Subjects who treated with metabolizing enzyme inducers or inhibitors such as barbitals within 30days prior to the first dosing.
- •Smoker ( ≥ 20cigarettes/day)
- •Subjects who takes ETC or OTC medicine within 10days before the first IP administration.
- •Subjects who do the whole blood donation within two months or component blood donation within 1month prior to the first dosing.
- •Subjects who can increase risk due to clinical test and administration of drugs or has Severe grade / chronic medical, mental condition or abnormal laboratory result that may interfere with the analysis of test results.
- •Patients with hypersensitivity to lobeglitazone or any other thiazolidinediones ( Rosiglitazone, Rioglitazone) and to Metformin or any other biguanides
- •Patients with severe heart failure or congestive heart failure of needing drug therapy
- •Patients with liver disease
- •Patients with severe renal disease
- •Patients with diabetes mellitus with ketoacidosis, diabetes coma and prior
- •Patients before or after surgery, with severe infections, severe trauma
- •Subjects with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients with renal disease or renal failure caused by cardiovascular collapse, acute myocardial infarction, sepsis (Serum creatinine ≥ 1.5mg/dL or abnormal creatine clearance)
- •Patients who had a test to injecting radioactive iodine in vein
- •Patients with severe infections or severe traumatic whole body injuries
- •Patients with undernourishment condition or starvation state or hyposthenia or hypopituitarism, or hypoadrenalism
- •Patients with respiratory failure, or stomach disease
- •Subjects who is not able to intake high fat meals
- •Subjects who is not able to comply with guidelines described in the protocol.
- •Subjects who is determined by investigator's decision as unsuitable for clinical trial participation.
研究组 & 干预措施
RT group
R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T)
干预措施: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg (Drug)
RT group
R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T) T: Test drug(CKD-395 0.25/750 mg 2T)
干预措施: CKD-395 0.25/750mg (Drug)
TR group
T: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T)
干预措施: Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg (Drug)
TR group
T: Test drug(CKD-395 0.25/750 mg 2T) R: Reference drug(Duvie Tab. 0.5mg 1T, Glucodaun OR Tab. 750mg 2T)
干预措施: CKD-395 0.25/750mg (Drug)
结局指标
主要结局
AUClast of Lobeglitazone
时间窗: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
AUClast of metformin
时间窗: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
Cmax of Lobeglitazone
时间窗: Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs
Cmax of Lobeglitazone Metformin
时间窗: Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs
次要结局
- Tmax of Lobeglitazone(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- AUCinf of Lobeglitazone(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- t1/2 of Metformin(Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- Vd/F of Lobeglitazone(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- Vd/F of Metformin(Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- CL/F of Lobeglitazone(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)
- AUCinf of Metformin(Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- CL/F of Metformin(Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- Tmax of Metformin(Metformin: 0(Pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 and 48hrs)
- t1/2 of Lobeglitazone(Lobeglitazone: 0(Pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 and 48hrs)