Drug-drug Interactions Between DWP14012 and DWC202202 in Healthy Subjects
Phase 1
Completed
- Conditions
- Drug Drug Interaction
- Interventions
- Registration Number
- NCT05574374
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
-
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.
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 3 DWC202203 * 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 Cohort 2 DWP14012 * 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 Cohort 1 DWC202202 * 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 Cohort 2 DWC202202 * 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 Cohort 3 DWP14012 * 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 Cohort 3 DWC202202 * 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 Cohort 1 DWP14012 * 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 Cohort 1 DWC202203 * 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 Cohort 2 DWC202203 * 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
- Primary Outcome Measures
Name Time Method Emax up to 50 days AUEC0-24 up to 50 days
- Secondary Outcome Measures
Name Time Method 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 Cavg,ss up to 50 days DWC202202 CLss/F 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of