Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin and Empagliflozin or Dapagliflozin in Healthy Male Adults

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT03766724
Phase
PHASE1
Status
Completed

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
MALE
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic and Pharmacodynamic Drug-Drug Interaction of Evogliptin 5 mg and Empagliflozin 25 mg or Dapagliflozin 10 mg after Oral Administration in Healthy Male Adults

Key Dates

Start date
Nov 22, 2018
Status verified
Apr 2019
Primary completion
Jan 18, 2019
Completion
Jan 18, 2019

Study Design

Enrollment
42 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Group A
    Evogliptin→Evogliptin+Empagliflozin→Empagliflozin
  • Experimental: Group B
    Empagliflozin→Evogliptin→Evogliptin+Empagliflozin
  • Experimental: Group C
    Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin
  • Experimental: Group D
    Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin

Primary Outcome Measure

AUCτ,ss [ Time Frame: 4 weeks ]

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