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

NCT ID: NCT05162274

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-01-14

Brief Summary

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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

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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

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Healthy Adult Volunteers

Keywords

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YH25448 Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lazertinib(G001)

Intervention Type DRUG

Current formulation

Lazertinib(G002)

Intervention Type DRUG

New formulation

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.

Group Type EXPERIMENTAL

Lazertinib(G001)

Intervention Type DRUG

Current formulation

Lazertinib(G002)

Intervention Type DRUG

New formulation

Interventions

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Lazertinib(G001)

Current formulation

Intervention Type DRUG

Lazertinib(G002)

New formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male, over 19 years of age
* Male participants must agree to use an adequate contraception method from the first to the third month after the last dose.
* Participants must have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive(BMI = weight/height2), and body weight not less than 50 kg.
* Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis.
* Participants must be healthy on the basis of clinical laboratory tests performed at screening.
* Informed of the investigational nature of this study and voluntarily agree to participate in this study.

Exclusion Criteria

* Clinically significant medical or psychiatric illness.
* Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg).
* A marked baseline prolongation of QTc.
* Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications
* Participants who are planning COVID-19 vaccine within 14 days before the first intake of study drug and to the end of the trials.
Minimum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development and Medical Department

Role: STUDY_DIRECTOR

Yuhan Corporation

Locations

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Seoul National University Hospital Clinical Trial Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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YH25448-102

Identifier Type: -

Identifier Source: org_study_id