Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.

Sponsor
Yuhan Corporation
Study ID
NCT05162274
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Adult Volunteers

Eligibility Criteria

Sex
MALE
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

This Clinical Trial is an open, randomized, fasted, single-dose, oral administration 2-sequence, 2-period crossover study to assess bioequivalence of lazertinib between two formulations in healthy adult volunteers. The subjects administer 240mg of lazertinib of different formulations on the fasted status on each period and have a wash-out period for 14-21 days between the first and second period.

Key Dates

Start date
Nov 30, 2021
Status verified
Feb 2022
Primary completion
Jan 14, 2022
Completion
Jan 14, 2022

Study Design

Enrollment
38 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Participants first received lazertinib(G001) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G002) 240mg in a fasting state morning for 1 day.
  • Experimental: Group 2
    Participants first received lazertinib(G002) 240mg tablet morning in a fasting state for 1 day. After a washout period of 14\~21days, they then received lazertinib(G001) 240mg in a fasting state morning for 1 day.

Primary Outcome Measure

AUClast of YH25448 [ Time Frame: 0 - 168 hours ]