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

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05568121
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.8
• Patients Per Site Per Month: 27.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: L04RD1; Drug: L04TD1; Drug: L04TD1; Drug: L04RD1	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Single-dose, Two-sequence, Two-period, Cross-over Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD1 and L04RD1 in Healthy Adult Volunteers
• Actual Study Start Date: Sep 1, 2022
• Actual Primary Completion Date: Oct 9, 2022
• Actual Study Completion Date: Oct 27, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A (L04RD1 -> L04TD1) Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1	Drug: L04RD1; 1 tablet of L04RD1; Drug: L04TD1; 1 tablet of L04TD1
Experimental: B (L04TD1 -> L04RD1) Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1	Drug: L04TD1; 1 tablet of L04TD1; Drug: L04RD1; 1 tablet of L04RD1

Outcome Measures

Primary Outcome Measures

1. 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]

2. 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

1. 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]

2. 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]

3. 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]

4. 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]

5. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H plus Yangji Hospital	Seoul		Korea, Republic of	08756

Sponsors and Collaborators

• Celltrion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT05568121
• Other Study ID Numbers: CT-L04-101
• First Posted: Oct 5, 2022
• Last Update Posted: Jan 12, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 12, 2023