Drug Drug Interaction
Conditions
Brief summary
This is a randomized, open-label study to evaluate the safety/tolerability and PK/PD drug-drug interactions between DWP14012 and aspirin when administered in combination.
Interventions
DRUGDWP14012
Potassium-competitive acid blocker
DRUGAspirin
acetylsalicylic acid
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
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. * For women, negative urine pregnancy test (hCG) at the screening visit
Exclusion criteria
* Subjects with hypersensitivity or history of clinically significant hypersensitivity to drugs including potassium competitive acid blocker \[P-CAB\] class, aspirin, salicylic acid, or other drugs (non-steroidal anti-inflammatory drug \[NSAIDs\], antibiotics, etc.) * Women who are or may be pregnant, or are breast-feeding * Subjects with a history related to blood clotting disorder or bleeding * Subjects with a medical diagnosis of functional constipation * 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, and disagreed to refrain from donating sperms during this period * Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of aspirin | Up to 21 days |
| Cmax,ss of DWP14012 | Up to 13 days |
| Emax | Up to 21 days |
| AUClast of aspirin | Up to 21 days |
| AUCτ,ss of DWP14012 | Up to 13 days |
| time to Emax | Up to 21 days |
| AUEC | Up to 21 days |
Countries
South Korea
Outcome results
None listed