NCT05812404进行中（未招募）1 期
A Randomized, Open-label, Three-period, Three-sequence, Multiple Dosing Crossover, Phase 1 Clinical Trial to Evaluate the Effect of DWP14012 on the Pharmacokinetics of DWC202201 After Co-administration of DWP14012 and DWC202201 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10月26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
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
研究概览
简要总结
A randomized, open-label, three-period, three-sequence, multiple dosing crossover, phase 1 clinical trial to evaluate the effect of DWP14012 on the pharmacokinetics of DWC202201 after co-administration of DWP14012 and DWC202201 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 disease or a history related to hepatobiliary system, kidney(severe kidney disorder ect.), nervous system, respiratory system, digestive system, endocrine system, hematology system, circulatory system(Heart failure, Torsades de pointes ect.), unrinary system, psychiatry ect.
- •Subjects with digestive disease(gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal disease, Crohn's disease) or history of surgery(except appendectomy, hernia surgery) which can affect on saftey and pharmacodynamics
- •Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker [P-CAB] class, aspirin, antibiotics, etc.
- •Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- •Subjects with history of inherited muscle disorders
- •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 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 unable to refrain from smoking(>10pieces/day) from 3 days prior to the first scheduled dose until last discharge from hospital
- •Subjects with alchoholic disorders or subjects who are unable to refrain from drinking(>21units/week) from 3 days prior to the first scheduled dose until last discharge from hospital
- •Subjects who are unable to refrain from caffein(>5units/day) from 3 days prior to the first scheduled dose until last discharge from hospital
研究组 & 干预措施
Cohort 3
Experimental
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
- Treatment C: DWP14012 40 mg qd for 14 days
- Treatment A: DWC202201 40 mg qd for 7 days
干预措施: DWP14012 (Drug)
Cohort 1
Experimental
- Treatment A: DWC202201 40 mg qd for 7 days
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
- Treatment C: DWP14012 40 mg qd for 14 days
干预措施: DWP14012 (Drug)
Cohort 3
Experimental
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
- Treatment C: DWP14012 40 mg qd for 14 days
- Treatment A: DWC202201 40 mg qd for 7 days
干预措施: DWC202201 (Drug)
Cohort 1
Experimental
- Treatment A: DWC202201 40 mg qd for 7 days
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
- Treatment C: DWP14012 40 mg qd for 14 days
干预措施: DWC202201 (Drug)
Cohort 2
Experimental
- Treatment C: DWP14012 40 mg qd for 14 days
- Treatment A: DWC202201 40 mg qd for 7 days
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
干预措施: DWP14012 (Drug)
Cohort 2
Experimental
- Treatment C: DWP14012 40 mg qd for 14 days
- Treatment A: DWC202201 40 mg qd for 7 days
- Treatment B: DWP14012 40 mg qd for 7 days, followed by DWC202201 40 mg qd + DWP14012 40 mg qd for 7 days
干预措施: DWC202201 (Drug)
结局指标
主要结局
Atorvastatin Peak Plasma Concentration at steady state (Cmax,ss) after DWC202201 multiple dosing
时间窗: [Time Frame: up to 64 days]
Atorvastatin Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing
时间窗: [Time Frame: up to 64 days]
次要结局
- Atorvastatin Apparent total body clearance at steady state (CLss/F) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin active metabolite Area under the plasma concentration versus time curve at steady state (AUCinf, ss) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin active metabolite An estimate of the total body clearance at steady state (CL ss/F) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin active metabolite Apparent volume of distribution at steady state (Vd,ss/F) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin Area under the plasma concentration extrapolated to infinity at steady state (AUC,ss) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin Time to peak drug concentration at staedy state (Tmax, ss) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Time of Maximum Concentration at steady state (Tmax,ss) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin active metabolite Terminal Half-life at steady state (T1/2,ss) after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Peak Plasma Concentration (Cmax) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Terminal Half-life (t1/2) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Apparent Clearance (CL/F) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Apparent Volume of Distribution After extravascular administration (Vd/F) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Peak Plasma Concentration at steady state (Cmax,ss) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Aapparent volume of distribution after extravascular administration at steady state (Vd,ss/F) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Atorvastatin active metabolite metabolic ratio after DWC202201 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Terminal Half-life at steady state (t1/2,ss) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan An estimate of the total body clearance at steady state (CL ss/F) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite The time of peak concentration (Tmax) after single dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite metabolic ratio after single dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite Peak Plasma Concentration at steady state (Cmax,ss) after multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite AUCtau,ss AUCinf,ss Tmax,ss metabolic ratio([Time Frame: up to 64 days])
- Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau at steady state (AUCtau,ss) after multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity at steady state (AUCinf,ss) after multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite The time of peak concentration at steady state (Tmax,ss) after multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite metabolic ratio after multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity(AUCinf) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan The time of peak concentration (Tmax) after DWP14012 single dosing([Time Frame: up to 64 days])
- Fexuprazan Area under the plasma drug concentration-time curve from 0 to infinity at steady state (AUCinf,ss) after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan Accumulation ratio after DWP14012 multiple dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite Peak Plasma Concentration (Cmax) after single dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite Area under the plasma drug concentration-time curve from 0 to tau (AUCtau) after single dosing([Time Frame: up to 64 days])
- Fexuprazan active metabolite Area under the plasma concentration extrapolated to infinity (AUCinf) after single dosing([Time Frame: up to 64 days])
研究者
研究点 (1)
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