A Clinical Trial to Compare and Evaluate the Safety and Bioequivalence of After Concomitant Administration of "SIPS-2209-2" and "SIPS-2209-3" and Single Administration of "SIPS-2209-1" in Healthy Adult Volunteers in Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUCt of SIPS-2209-1
研究概览
简要总结
The goal of this clinical trial is to evaluate of bioequivalence between fixed-dose combination and co-administration of the individual components under fasting conditions in healthy Korean volunteers.
详细描述
40 healthy subjects are administered the corresponding drug for each period, and the drug wash-out period is set to 7 days. Pharmacokinetic samples are collected for up to 36 hours. Pharmacokinetic parameters are compared to evaluate bioequivalence, and additionally, safety are evaluated.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19 years
- •Male for body weight ≥50 kg, female for body weight ≥45 kg
- •Calculated body mass index (BMI) of 18 to 30 kg/m2
- •Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
- •Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serology, urology) and ECG results at screening.
- •Those who agree to contraception during the participation of clinical trial.
- •Those who agrees to exclude the possibility of pregnancy by using a medically accepted method of contraception from the first administration of investigational medicine to 7 days after the last administration of investigational medicine
排除标准
- •Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- •Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month and those who take drug could affect to clinical trial within 10 days before the first administration of investigational products.
- •Those who donated whole blood or apheresis within 8 weeks or 2 weeks respectfully, or received blood transfusion within a month.
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- •Those who exceed an alcohol and cigarette consumption criteria write below within 1 month before the first administration of investigational products.
- •Alcohol: Man - 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL)
- •Patients with the following diseases
- •Patients with known hypersensitivity reactions such as anaphylaxis or angioedema to investigational drugs and components
- •Patients with pancreatitis
- •Patients with heart failure or a history of heart failure
- •Patients with active bladder cancer or a history of bladder cancer
- •Patients with hepatic impairment
- •Patients with severe renal impairment
- •Patients with diabetic ketoacidosis, diabetic coma and pre-coma, patients with type 1 diabetes
- •Before and after surgery, patients with severe infections, patients with severe trauma
- •Patients with gross hematuria not investigated
- •Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- •Those who are deemed insufficient to participate in this clinical trial by investigators.
- •Woman who are pregnant or breastfeeding.
- •Those who have a history of clinically significant mental illness
研究组 & 干预措施
Sequence A
Period 1: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition
Period 2: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition
干预措施: SIPS-2209-1 (Drug)
Sequence A
Period 1: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition
Period 2: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition
干预措施: SIPS-2209-2, SIPS-2209-3 (Drug)
Sequence B
Period 1: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition
Period 2: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition
干预措施: SIPS-2209-1 (Drug)
Sequence B
Period 1: SIPS-2209-2, SIPS-2209-3 - A single oral dose of 2 tablets under fasting condition
Period 2: SIPS-2209-1 - A single oral dose of 1 tablet under fasting condition
干预措施: SIPS-2209-2, SIPS-2209-3 (Drug)
结局指标
主要结局
AUCt of SIPS-2209-1
时间窗: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of SIPS-2209-1
时间窗: predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours
Cmax: Maximum plasma concentration of the drug
次要结局
- t1/2 of SIPS-2209-1(predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours)
- CL/F of SIPS-2209-1(predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours)
- Vd/F of SIPS-2209-1(predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours)
- Tmax of SIPS-2209-1(predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours)
- AUCinf of SIPS-2209-1(predose (0 hours), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36 hours)