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

Celltrion Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: L04RD1; Drug: L04TD1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05568121

CT-L04-101

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 19 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

A (L04RD1 -> L04TD1)

Experimental group

Description:

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

Treatment:

Drug: L04RD1

Drug: L04RD1

Drug: L04TD1

Drug: L04TD1

B (L04TD1 -> L04RD1)

Experimental group

Description:

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

Treatment:

Drug: L04RD1

Drug: L04RD1

Drug: L04TD1

Drug: L04TD1