Status:
RECRUITING
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Healthy Subjects
Eligibility:
All Genders
19-64 years
Phase:
PHASE1
Brief Summary
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
Detailed Description
This is an open-label, randomized, single-dose, two-treatment, two-period, crossover, phase 1 clinical trial conducted under fasting conditions to compare and evaluate the pharmacokinetics (PK) and sa...
Eligibility Criteria
Inclusion
- Male or female participants aged ≥19 years and \<65 years at the time of screening
- Body mass index (BMI) between 18 and 30 kg/m² (BMI = weight \[kg\] / height \[m\]²)
Exclusion
- Subjects who have participated in a bioequivalence study or any other clinical trial and have received an investigational product within 6 months prior to the first administration.
- Subjects who have donated whole blood within 8 weeks prior to the first administration, donated blood components within 2 weeks prior to the first administration, or received a blood transfusion within 4 weeks prior to the first administration.
- Subjects with a history of gastrointestinal surgery that may affect drug absorption (appendectomy and hernia repair are not exclusionary).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07144176
Start Date
September 1 2025
End Date
September 1 2025
Last Update
August 28 2025
Active Locations (1)
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1
H Plus Yangji Hospital
Seoul, South Korea, 08779