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

NCT05162274 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-12-11

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Adult Volunteers

Interventions

DRUG

Lazertinib(G001)

Current formulation

DRUG

Lazertinib(G002)

New formulation

Sponsors & Collaborators

  • Yuhan Corporation

    lead INDUSTRY

Principal Investigators

  • Clinical Development and Medical Department · Yuhan Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2022-01-14
Completion
2022-01-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162274 on ClinicalTrials.gov