The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

Sponsor
Dong-A ST Co., Ltd.
Study ID
NCT04195919
Phase
PHASE1
Status
Completed

Conditions

  • Hemodialysis Patients

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Evogliptin 5mg — DRUG
    Participants receive Single oral administration of Evogliptin 5mg on day1
  • Evogliptin 5mg — DRUG
    Period 1(1d,After hemodialysis) → Wash-out period → Period 2(15d,Before hemodialysis) Hemodialysis patients receive Single oral administration of Evogliptin 5mg on day1 and day15 With a 14-day washout period

Study Details

A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients

Key Dates

First listed
Dec 12, 2019
Start date
Jul 10, 2020
Status verified
Nov 2021
Primary completion
May 24, 2021
Completion
May 24, 2021

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Group1
    Hemodialysis patients(MDRD-eGFR ≤ 15 mL/min/1.73m2)
  • Experimental: Group2
    Healthy control(MDRD-eGFR ≥ 90 mL/min/1.73m2)

Primary Outcome Measure

AUClast [ Time Frame: 1day(15day) pre-dose (0), 1, 2, 3, 4, 5, 6, 7, 8, 12, 24, 36, 48 hour post-dose ]