Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT02753803
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

Study Details

A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Key Dates

First listed
Apr 28, 2016
Start date
Jul 27, 2016
Status verified
Sep 2017
Primary completion
Oct 19, 2016
Completion
Mar 10, 2017

Study Design

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

Arms

  • Experimental: A group
    Evogliptin Pioglitazone Evogliptin+Pioglitazone
  • Experimental: B group
    Pioglitazone Evogliptin Evogliptin+Pioglitazone
  • Experimental: C group
    Evogliptin Evogliptin+Pioglitazone Pioglitazone
  • Experimental: D group
    Pioglitazone Evogliptin+Pioglitazone Evogliptin
  • Experimental: E group
    Evogliptin+Pioglitazone Evogliptin Pioglitazone
  • Experimental: F group
    Evogliptin+Pioglitazone Pioglitazone Evogliptin

Primary Outcome Measure

AUC [ Time Frame: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose ]

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