NCT05089279已完成1 期
An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- AUCt of CKD-349
研究概览
简要总结
Study to Evaluate the Safety and Pharmacokinetics of CKD-349
详细描述
An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 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 ≥50kg (man) or 45kg (woman), 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 until 7 days after 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 clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
- •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 or take drugs that may interfere with this clinical trials within 10 day before the first administration
- •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 within 8 weeks or donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
- •Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
- •Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
- •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 1
Experimental
Period 1: D113/ Period 2: CKD-349
干预措施: D113 (Drug)
Sequence 1
Experimental
Period 1: D113/ Period 2: CKD-349
干预措施: CKD-349 (Drug)
Sequence2
Experimental
Period 1: CKD-349/ Period 2: D113
干预措施: D113 (Drug)
Sequence2
Experimental
Period 1: CKD-349/ Period 2: D113
干预措施: CKD-349 (Drug)
结局指标
主要结局
AUCt of CKD-349
时间窗: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
AUCt: Area under the concentration-time curve from time zero to time
Cmax of CKD-349
时间窗: 0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax: Maximum plasma concentration of the drug
次要结局
- AUCinf of CKD-349(0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- Tmax of CKD-349(0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- T1/2 of CKD-349(0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
- AUCt/AUCinf of CKD-349(0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours)
研究者
研究点 (1)
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