A Clinical Trial to Evaluate the Food Effect on Pharmacokinetic Profiles and Safety of CKD-379

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT06204107
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 54 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 21, 2023
Status verified
Jan 2024
Primary completion
Dec 6, 2023
Completion
Dec 6, 2023

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    * Phase 1: CKD-379 Test drug * Phase 2: CKD-379 Reference drug
  • Experimental: Group 2
    * Phase 1: CKD-379 Reference drug * Phase 2: CKD-379 Test drug

Primary Outcome Measure

AUCt of Empagliflozin, sitagliptin, metformin [ Time Frame: 0 hour ~ 48 hour after drug administration ]

Related Studies