An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Cmax of CKD-331
研究概览
简要总结
Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers
详细描述
An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers
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
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged ≥ 19 years
- •Weight ≥55kg with 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 12-lead ECG results at screening.
- •Those who agree to contraception during the participation of clinical trial.
- •Individuals who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.
排除标准
- •Those who have no medical history of digestive disease, cardiovascular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, immunological disease, otolaryngological disease, dermatological disease, ophiological disease
- •Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
- •Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products.
- •Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
- •Those who donated whole blood or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.
- •Those who exceed an alcohol and cigarette consumption than below criteria Alcohol
- •Man: 21 glasses/week
- •Woman: 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Smoking: 20 cigarettes/day
- •Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
- •Those who are deemed insufficient to participate in this clinical study by investigators.
- •Woman who are pregnant or breastfeeding.
研究组 & 干预措施
Sequence A
Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition
干预措施: CKD-331 (Drug)
Sequence A
Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition
干预措施: EX5619 (Drug)
Sequence B
Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition
干预措施: CKD-331 (Drug)
Sequence B
Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition
Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition
Period 4: EX5619 - A single oral dose of 1 tablet under fasting condition
干预措施: EX5619 (Drug)
结局指标
主要结局
Cmax of CKD-331
时间窗: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours
Cmax: Maximum plasma concentration of the drug
AUCt of CKD-331
时间窗: Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours
AUCt: Area under the concentration-time curve from time zero to time
次要结局
未报告次要终点