Status:
COMPLETED
Pharmacokinetics and Safety Following Administration of DWP16001
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
To compare and evaluate the safety and pharmacokinetic characteristics after administration of DWP16001 Drug A and DWP16001 Drug B in healthy adult volunteers
Eligibility Criteria
Inclusion
- Healthy adult volunteers aged ≥ 19 years at screening
- Subjects with a body weight of ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2
- Subjects with no congenital or chronic disease that requires treatment, and no clinical symptoms or findings based on medical examination
- Subjects who are determined eligible to participate in this study based on results of laboratory tests, vital signs, physical examination etc at screening.
Exclusion
- Current or history of clinically significant hepatic, renal, nervous, respiratory, endocrine, hemato-oncology, cardiovascular, urogenital, psychosis disorder
- Current or history of gastrointestinal disorders or prior history of gastrointestinal surgery that may affect safety and PK/PD assessment of the study drug
- Clinical laboratory test values are outside the accepted normal range at screening
- Other exclusive inclusion criteria, as defined in the protocol
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05414591
Start Date
May 1 2021
End Date
August 1 2021
Last Update
July 13 2022
Active Locations (1)
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1
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea, 13496