Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448

Sponsor
Yuhan Corporation
Study ID
NCT03556436
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • YH25448 240mg — DRUG
    period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast

Study Details

Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.

Key Dates

Start date
Jul 3, 2018
Status verified
Jan 2019
Primary completion
Dec 30, 2018
Completion
Dec 30, 2018

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    YH25448 240mg single dose in korean
  • Experimental: Group 2
    YH25448 240mg single dose in caucasian

Primary Outcome Measure

AUClast of YH25448 [ Time Frame: 0-192 hrs ]

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