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
Overview
- Phase
- Phase 1
- Intervention
- CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- AUCt of Empagliflozin, sitagliptin, metformin
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
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
- •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
Arms & Interventions
Group 1
* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
Intervention: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
Group 1
* Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
Intervention: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
Group 2
* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug
Intervention: CKD-379(Empagliflozin+sitagliptin+metformin) Test drug
Group 2
* Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug
Intervention: CKD-379(Empagliflozin+sitagliptin+metformin) Reference drug
Outcomes
Primary Outcomes
AUCt of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Cmax of Empagliflozin, sitagliptin, metformin
Time Frame: 0 hour ~ 48 hour after drug administration
Secondary Outcomes
- CL/F of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- Tmax of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- t1/2 of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- AUCinf of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)
- Vd/F of Empagliflozin, sitagliptin, metformin(0 hour ~ 48 hour after drug administration)