A Bioequivalence Study of L04TD2 Compared to Administration of L04RD1 in Healthy Volunteers

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05581693
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 2
• Patients Per Site Per Month: 25.4

Study Details

Study Description

Brief Summary

This is a randomized, open, single-dose, crossover-design, phase 1, singlecenter study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD2 in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: L04RD1; Drug: L04TD2; Drug: L04TD2; 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, Crossover Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of L04TD2 and L04RD1 in Healthy Adult Volunteers
• Actual Study Start Date: Sep 30, 2022
• Actual Primary Completion Date: Nov 1, 2022
• Actual Study Completion Date: Nov 29, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A (L04RD1 -> L04TD2) Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD2	Drug: L04RD1; 1 tablet of L04RD1; Drug: L04TD2; 1 tablet of L04TD2
Experimental: B (L04TD2 -> L04RD1) Administration of 1 tablet of L04TD2, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1	Drug: L04TD2; 1 tablet of L04TD2; 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 aged 19 to less than 65 years at the time of the screening visit

• A subject with a body weight of 55kg or higher and a body mass index (BMI) of 18.0 kg/m2 to 29.9 kg/m2, inclusive

• A subject considered appropriate to participate in the study according to the results of lab tests such as the hematological test, blood chemistry test, serum test, urinalysis, etc. and ECG set and conducted by the principal investigator (or a delegated study physician) according to the characteristics of the investigational product

• A subject who agreed to exclude the possibility of pregnancy by having themselves, their spouses, or partners use medically appropriate contraceptive methods and not to provide sperm or egg from the first dose to 7 days after the last dose of IP administration

• A subject who voluntarily signed the informed consent form after listening to and understanding sufficient explanation on the purpose, content of this clinical study, the characteristics of the investigational product, expected adverse events, etc.

Exclusion Criteria:

• A subject who has clinically significant diseases in the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infectious disease, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otolaryngeal system, skin system, and ophthalmic system or has had the diseases

• A subject who had gastrointestinal surgery (excluding simple appendectomy or hernia surgery) which may affect the absorption of drugs or have gastrointestinal diseases

• A subject who took drugs that induce and inhibit drug metabolizing enzymes such as barbiturates within one month from the first administration date or drugs that might affect this clinical study within 10 days from the first administration date (subjects may participate depending on the pharmacodynamics and pharmacokinetics such as the interactions with the investigational product, half-life, etc.)

• A subject who participated in another clinical study or bioequivalence study where they were administered the investigational product within 6 months prior to the first dose of the investigational drug

• A subject considered by the principal investigator (or a delegated study physician) as inappropriate to participate in this clinical study due to reasons other than the above inclusion and exclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jaewoo Kim	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: NCT05581693
• Other Study ID Numbers: CT-L04-102
• First Posted: Oct 14, 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