Drug Drug Interaction
Conditions
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
Interventions
DRUGDWP14012
Potassium-competitive acid blocker
DRUGDWC202202
Clopidogrel Bisulfate
DRUGDWC202203
Proton pump inhibitor
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Emax | up to 50 days |
| AUEC0-24 | up to 50 days |
Secondary
| Measure | Time frame |
|---|---|
| DWC202202 Cmax,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 Tmax,ss | up to 50 days |
| DWC202202 active metabolite Tmax,ss | up to 50 days |
| DWC202202 t1/2,ss | up to 50 days |
| DWC202202 active metabolite t1/2,ss | up to 50 days |
| DWC202202 Cmin,ss | up to 50 days |
| DWC202202 active metabolite Cmin,ss | up to 50 days |
| DWC202202 Cavg,ss | up to 50 days |
| DWC202202 active metabolite 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 R | up to 50 days |
| DWC202202 active metabolite MR | up to 50 days |
Countries
South Korea
Outcome results
None listed