A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate Drug-drug Interactions and Safety Between CKD-501, D759, and D150 in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax,ss of CKD-501, D759, D150
研究概览
简要总结
A Clinical trial to investigate the pharmacokinetic drug interaction and safety of CKD-501, D759 and D150
详细描述
A Randomized, Open-label, 2-Part, Multiple-dose, Two-way Crossover Clinical Trial to Evaluate Drug-drug Interactions and safety between CKD-501, D759, and D150 in Healthy Adult
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
- All
- 接受健康志愿者
- 是
入选标准
- •Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
- •Healthy adult volunteers aged between 19 and 55-year-old
- •Weight ≥ 50kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 18.0 to 30.0 kg/m2
排除标准
- •Those who have history of hypersensitivity to active pharmaceutical ingredient (Lobeglitazone, Sitagliptin, Metformin) or additives.
- •Those who have clinically significant disease or medical history of Hepatopathy, Renal dysfunction, Neurological disorder, Immunity disorder, Respiratory disorder, Genitourinary system disorder, Digestive system disorder, Endocrine system disorder, Cardiovascular disorder, Blood tumor, Psychical disorder, Severe urinary tract infection
- •Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug
- •Those who have Drug abuse (especially sleeping drugs, central analgesics, opiates or psychotropic drugs such as psychotropic drugs) or persons with a history of substance abuse
- •Those who have the test results written below
- •AST, ALT > 1.25 times higher than upper normal level
- •Total bilirubin > 1.5 times higher than upper normal level
- •eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) < 60 mL/min/1.73m2
- •"Positive" or "Reactive" test result of Hepatitis B & C, HIV, RPR
- •Under 5 min resting condition, systolic blood pressure >150 mmHg or <90 mmHg, diastolic blood pressure >100 mmHg or <50 mmHg
- •Those who have determined that the abnormal results are clinically significant in the screening test items (question, vital signs, electrocardiogram, physical test, blood, urine test, etc.)
- •Those who have participated in other clinical trials within 180 days of the intended study drug administration and have been administered clinical trial medications (except for those who have not taken the study medication)
- •Those who has taken a drug (specialized drug, generic drug, herbal medicine, or nutritional supplement (vitamin, etc.)) within 2 weeks prior to screening (however, if it is considered that it does not affect the safety and research results of the subject, as determined by the investigator) You can participate in the test.)
- •Those who donated whole blood within 8 weeks prior to screening, or who donated or donated components (plasma, platelets) within 4 weeks, and consented to prohibit blood donation from 30 days after the last dose Not.
- •Those who have continuously consumed more than 21 units/week (1 unit of alcohol = 10 g = 12.5 mL) within 6 months prior to screening
- •Those who have More than 10 smokers a day within 6 months prior to screening
- •Those who cannot use clinically acceptable contraceptive methods (e.g., infertility surgery between themselves and partners, intrauterine contraceptive devices, use of diaphragms or condoms) from the time the drug is administered to the last visit
- •Those who cannot inhibit the diet (especially grapefruit juice, caffeine) that can affect the absorption, distribution, metabolism, and excretion of the drug from 3 days before the last administration of the investigational drug to the last visit.
- •Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Those who receive intravenous administration of radioactive iodine contrast agents (for intravenous urography, venous cholangiography, angiography, computed tomography using contrast agents, etc.) within 48 hours before the first administration of investigational product
- •Those who are pregnant or breastfeeding
- •Those who are deemed inappropriate to participate in clinical trial by investigators
研究组 & 干预措施
Sequence 1
Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days.
Period 2: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
干预措施: CKD 501 (Drug)
Sequence 2
Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days
干预措施: CKD-501, D759, D150 (Drug)
Sequence 1
Period 1: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days.
Period 2: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D759, D150 (Drug)
Sequence 2
Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
Period 2: CKD-501 - A single oral dose of 1 tablet under fasting conditions for 5 days
干预措施: CKD 501 (Drug)
Sequence 3
Period 1: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets).
Period 2: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
干预措施: D759, D150 (Drug)
Sequence 3
Period 1: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets).
Period 2: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D759, D150 (Drug)
Sequence 4
Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
Period 2: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets).
干预措施: D759, D150 (Drug)
Sequence 4
Period 1: CKD-501, D759, D150 - A single oral dose of 4 tablets under fasting conditions for 5 days (CKD-501: 1 tablet, D759: 1 tablet, D150: 2 tablets).
Period 2: D759, D150 - A single oral dose of 3 tablets under fasting conditions for 5 days (D759: 1 tablet, D150: 2 tablets).
干预措施: CKD-501, D759, D150 (Drug)
结局指标
主要结局
Cmax,ss of CKD-501, D759, D150
时间窗: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
Cmax,ss: Maximum concentration of drug in plasma at steady state
AUCtau,ss of CKD-501, D759, D150
时间窗: CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours
AUCtau,ss: Area under the plasma drug concentration-time curve within a dosing interval(τ) at steady state
次要结局
- Cmin,ss of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)
- t1/2,ss of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)
- Vd,ss/F of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)
- Tmax,ss of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)
- CLss/F of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)
- Fluctuation of CKD-501, D759, D150(CKD-501: Day1, Day3, Day4 - Pre-dose(0 hour), Day5 - Pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours / D759,D150: Day1, Day3, Day4- Pre-dose(0 hour), Day5- Pre-dose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24hours)