Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT02954822
Phase
PHASE1
Status
Completed

Conditions

  • Type2 Diabetes

Eligibility Criteria

Sex
MALE
Age
19 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Evogliptin→Evogliptin+Glimepiride→Glimepiride — DRUG
    Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days. Glimepiride : Glimepiride 4mg QD Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD
  • Glimepiride→Evogliptin→Evogliptin+Glimepiride — DRUG
    After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.

Study Details

A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Key Dates

First listed
Nov 3, 2016
Start date
Nov 14, 2016
Status verified
Sep 2017
Primary completion
Jan 25, 2017
Completion
Aug 9, 2017

Study Design

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

Arms

  • Experimental: (Group A)
    Evogliptin→Evogliptin+Glimepiride→Glimepiride
  • Experimental: (Group B)
    Glimepiride→Evogliptin→Evogliptin+Glimepiride

Primary Outcome Measure

AUCτ,ss for Evogliptin and Glimepiride [ Time Frame: 3 weeks ]

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