NCT05162274

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

An Open-label, Randomized, Fasted, Single-dose, Oral Administration, 2-sequence, 2-period Crossover Study to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: Male
• Age: 19 Years
• Healthy volunteers: Accepted

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.

Detailed description

This clinical trial will be conducted in healthy male volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center. It is expected to take approximately 32 days from the first dosing of Investigational Product until the final follow-up visit. Subjects will be hospitalized twice for 4 nights and 5 days with 7-14 days of wash-out period, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.

Conditions

• Healthy Adult Volunteers

Interventions

Type	Name	Description
DRUG	Lazertinib(G001)	Current formulation
DRUG	Lazertinib(G002)	New formulation

Timeline

• Start date: 2021-11-30
• Primary completion: 2022-01-14
• Completion: 2022-01-14
• First posted: 2021-12-17
• Last updated: 2024-12-11

Locations

1 site across 1 country: South Korea