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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: L04RD1; Drug: L04TD2

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 08756
    • Jaewoo Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: L04RD1; 1 tablet of L04RD1; Drug: L04TD2; 1 tablet of L04TD2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: CT-L04-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No