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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: L04RD1
* Drug: L04TD1
* Drug: L04TD1
* Drug: L04RD1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |