A Bioequivalence Study of L04TD1 Compared to Administration of L04RD1 in Healthy Volunteers

NCT ID: NCT05568121

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-10-27

Brief Summary

This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A (L04RD1 -> L04TD1)

Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1

Group Type: EXPERIMENTAL

L04RD1

Intervention Type: DRUG

1 tablet of L04RD1

L04TD1

Intervention Type: DRUG

1 tablet of L04TD1

B (L04TD1 -> L04RD1)

Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1

Group Type: EXPERIMENTAL

L04TD1

Intervention Type: DRUG

1 tablet of L04TD1

L04RD1

Intervention Type: DRUG

1 tablet of L04RD1

Interventions

L04RD1

1 tablet of L04RD1

Intervention Type: DRUG

L04TD1

1 tablet of L04TD1

Intervention Type: DRUG

L04TD1

1 tablet of L04TD1

Intervention Type: DRUG

L04RD1

1 tablet of L04RD1

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A subject who weighs 50 kg or more at the screening visit and has a body mass index (BMI) of 18.0~29.9 kg/m2
• A subject who is judged to be eligible to participate by the results of screening tests (vital signs, clinical laboratory tests, 12-lead ECG, etc.) by the principal investigator within 30 days before the first administration of the investigational drug
• A subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 28 days after the last dose of the investigational drug
• A subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, thge characteristics of the investigational drugs, expected adverse reactions, and etc.

Exclusion Criteria

• A subject who has a history or present symptoms of clinically significant liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or psychiatric disease
• A subject who has an acute illness within 30 days prior to the first dose of investigational drug
• A subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases
• A subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month prior to the first administration
• A subject who has participated in other clinical trials or bioequivalence studies within 6 months prior to the first dose of the investigational drug
• A subject who is judged unsuitable to participate in this study by the principal investigator

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

H plus Yangji Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CT-L04-101

Identifier Type: -

Identifier Source: org_study_id