Status:
NOT_YET_RECRUITING
To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers
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 1 trial to evaluate the food effect on pharmacokinetic profiles and safety of CKD-383 in healthy volunteers
Detailed Description
Participants were randomly assigned in a 1:1 ratio. TheParticipants 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
- who has taken drug metabolism enzyme induction and inhibitory drugs, such as barbitale drugs, within 30 days prior to the start of the trial (Period
- 1 administration)
- Other exclusive criteria, as defined in the protocol
Key Trial Info
Start Date :
July 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 8 2024
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06492655
Start Date
July 4 2024
End Date
August 8 2024
Last Update
July 10 2024
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