Status:
COMPLETED
A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379
Lead Sponsor:
Chong Kun Dang Pharmaceutical
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-54 years
Phase:
PHASE1
Brief Summary
This is a randomized, open-label, single dose, crossover, phase Ⅰ trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-379 in healthy volunteers
Detailed Description
Participants were randomly assigned in a 1:1 ratio. The patients are prescribed oral administration of the appropriate IP(2 tablets in single dose: actual medication)
Eligibility Criteria
Inclusion
- Healthy adults aged 19 to 54 years
- BMI measurement result is 18.0 kg/m2 to 30 kg/m2
- Written informed consent
- Other inclusion criteria, as defined in the protocol
Exclusion
- History of clinically significant liver, kidney, blood, digestive, respiratory, endocrine, cardiovascular, neurological, mental, or immune system disorders
- AST or ALT or total bilirubin \> 1.5 times the upper limit of normal range
- History of regular alcohol consumption \> 21 units/week within 6 months at the time of screening
- Participated in a clinical trial within 6 months prior to 1st IP dosing
- Other exclusive inclusion criteria, as defined in the protocol
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2023
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06204107
Start Date
November 21 2023
End Date
December 6 2023
Last Update
January 12 2024
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam, South Korea