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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: L04RD1; Drug: L04TD1

• Registration Number: NCT05568121
• Lead Sponsor: Celltrion

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-05
• Primary Completion: 2022-10-09
• Study Completion: 2022-10-27
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (L04RD1 -> L04TD1)	L04RD1	Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1
A (L04RD1 -> L04TD1)	L04TD1	Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1
B (L04TD1 -> L04RD1)	L04TD1	Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1
B (L04TD1 -> L04RD1)	L04RD1	Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1

Primary Outcome Measures

Name	Time	Method
AUCt	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
Cmax	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

Secondary Outcome Measures

Name	Time	Method
AUCt/AUCinf	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
t1/2 (Half-life)	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
AUCinf (Area under the plasma concentration-time curve from time 0 to infinity)	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
Tmax (Time of peak plasma concentration)	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours
CL/F	Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours

Trial Locations

Locations (1)

H plus Yangji Hospital; 🇰🇷 Seoul, Korea, Republic of