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The objective of this clinical trial is to evaluate bioequivalence of "LCB01-0371 (Batch# 1650006)" and "LCB01-0371(Batch#3183817R) in healthy adult subject
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Period 1: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) Period 2: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) |
|
| Group B | Experimental | Period 1: LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) Period 2: LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R) | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic evaluation: The observed maximum concentration(Cmax) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours |
| Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUClast) | Area under the plasma concentration curve from zero until the last measurable concentration | 0-12hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic evaluation: Time to reach Cmax(Tmax) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours |
| Pharmacokinetic evaluation: Elimination half-life(t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae-Yong Chung | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39801777 | Derived | Koh J, Khwarg J, Cho YL, Yu KS, Chung JY. Comparative pharmacokinetics study of two tablet formulations of delpazolid, a novel oxazolidinone class antibiotic. Transl Clin Pharmacol. 2024 Dec;32(4):216-224. doi: 10.12793/tcp.2024.32.e18. Epub 2024 Dec 18. |
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| ID | Term |
|---|---|
| C000627008 | delpazolid |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |
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| LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006) | Drug | Oral administration |
|
Pharmacokinetic parameters will be assessed using non-compartmental method
| 0-12hours |
| Pharmacokinetic evaluation: Apparent total body clearance after extravascular administration(CL/F) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours |
| Pharmacokinetic evaluation:Apparent volume of distribution after extravascular administration(Vd/F) | Pharmacokinetic parameters will be assessed using non-compartmental method | 0-12hours |
| Pharmacokinetic evaluation:Area under the blood concentration-time curve (AUCinf) | Area under the curve from time 0 extrapolated to infinite time | 0-12hours |