NCT05574374已完成1 期
A Randomized, Open-label, Three-sequence, Three-period, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacodynamics of DWC202202 in Combination With DWP14012 in Healthy Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年9月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Emax
研究概览
简要总结
A randomized, open-label, three-sequence, three-period, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacodynamics of DWC202202 in combination with DWP14012 in healthy subjects
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged ≥ 19 and ≤ 50 years at screening
- •Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening
- •※ BMI (kg/m2) = body weight (kg)/[height (m)]2
- •Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
- •Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.
排除标准
- •Subjects with a history related to blood clotting disorder or bleeding
- •Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- •Subjects with a history of drug abuse or a positive result of using abusive drugs in the urine drug screen
- •Subjects who participated in other clinical trials (including bioequivalence studies) within 6 months prior to the first scheduled dose of the IP
- •Subjects who donated whole blood within 2 months, donated blood components within 1 month, or received blood transfusion within 1 month prior to the first scheduled dose
- •Subjects who are unable to refrain from grapefruit-containing products from 3 days prior to the first scheduled dose until last discharge from hospital
- •Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •Subjects or their spouses or partners who are unable to use medically acceptable appropriate double-method of contraception or medically acceptable contraception throughout the study period and for at least 4 weeks after the last IP administration
- •Subjects who are smoking
研究组 & 干预措施
Cohort 1
Experimental
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
干预措施: DWP14012 (Drug)
Cohort 1
Experimental
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
干预措施: DWC202202 (Drug)
Cohort 1
Experimental
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
干预措施: DWC202203 (Drug)
Cohort 2
Experimental
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
干预措施: DWP14012 (Drug)
Cohort 2
Experimental
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
干预措施: DWC202202 (Drug)
Cohort 2
Experimental
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
干预措施: DWC202203 (Drug)
Cohort 3
Experimental
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
干预措施: DWP14012 (Drug)
Cohort 3
Experimental
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
干预措施: DWC202202 (Drug)
Cohort 3
Experimental
- Treatment B: DWC202202 1 tablet qd + DWP14012 1 tablet qd for 7days
- Treatment C: DWC202202 1 tablet qd + DWC202203 1 tablet qd for 7days
- Treatment A: DWC202202 1 tablet qd for 7days
干预措施: DWC202203 (Drug)
结局指标
主要结局
Emax
时间窗: up to 50 days
AUEC0-24
时间窗: up to 50 days
次要结局
- DWC202202 Cmax,ss(up to 50 days)
- DWC202202 t1/2,ss(up to 50 days)
- DWC202202 active metabolite Cmax,ss(up to 50 days)
- DWC202202 AUCtau,ss(up to 50 days)
- DWC202202 active metabolite AUCtau,ss(up to 50 days)
- DWC202202 AUCinf,ss(up to 50 days)
- DWC202202 active metabolite AUCinf,ss(up to 50 days)
- DWC202202 active metabolite Tmax,ss(up to 50 days)
- DWC202202 Cmin,ss(up to 50 days)
- DWC202202 active metabolite Cmin,ss(up to 50 days)
- DWC202202 active metabolite Cavg,ss(up to 50 days)
- DWC202202 R(up to 50 days)
- DWC202202 Tmax,ss(up to 50 days)
- DWC202202 active metabolite t1/2,ss(up to 50 days)
- DWC202202 CLss/F(up to 50 days)
- DWC202202 Cavg,ss(up to 50 days)
- DWC202202 Vd,ss/F(up to 50 days)
- DWC202202 PTF (peak to trough fluctuation)(up to 50 days)
- DWC202202 active metabolite PTF (peak to trough fluctuation)(up to 50 days)
- DWC202202 active metabolite MR(up to 50 days)
研究者
研究点 (1)
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