Status:
COMPLETED
Drug-drug Interactions Between DWP14012 and Aspirin in Healthy Subjects
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Drug Drug Interaction
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 22 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05304845
Start Date
March 21 2022
End Date
May 22 2022
Last Update
April 5 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 03080