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
Overview
- Phase
- Phase 1
- Intervention
- CKD-383(Fed)
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 28
- Primary Endpoint
- AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Group 1
* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted)
Intervention: CKD-383(Fed)
Group 1
* Period 1: CKD-383 two tablets(Fed) * Period 2: CKD-383 two tablets(Fasted)
Intervention: CKD-383(Fasted)
Group 2
* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed)
Intervention: CKD-383(Fed)
Group 2
* Period 1: CKD-383 two tablets(Fasted) * Period 2: CKD-383 two tablets(Fed)
Intervention: CKD-383(Fasted)
Outcomes
Primary Outcomes
AUCt of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Time Frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization
Cmax of Empagliflozin, sitagliptin, metformin(Participants greater than or equal to 18.0 kg/m2 and less than 30 kg/m2)
Time Frame: 0 hour ~ 48 hour after drug administration
Pharmacokinetic characterization