Spots Global Cancer Trial Database for Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
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Trial Identification
Brief Title: Clinical Trial to Assess Bioequivalence of Lazertinib Between Two Formulations in Healthy Volunteers.
Official Title: 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
Study ID: NCT05162274
Conditions
Study Description
Brief 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.
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
Seoul National University Hospital Clinical Trial Center, Seoul, , Korea, Republic of
Contact Details
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