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The purpose of this study is to assess safety, tolerability of LCB01-0371 after fasting/non-fasting food taken in healthy male subjects.
A Randomized, Open-label, Single dose, Crossover, Phase â… Trial to evaluate the effect of food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1(RT):LCB01-0371 Tablet 800mg | Experimental |
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| Group 2(TR):LCB01-0371 Tablet 800mg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 Tablet 800 mg(R) | Drug | Reference: taken drug before meal |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse events | From date of randomization until follow up after 7 days from last hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: AUClast(Area under the plasma concentration) | 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours | |
| Pharmacokinetics: Cmax(Peak plasma concentration) | 0(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaeyong Chung, M.D., Ph.D | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Bundang | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| C000627008 | delpazolid |
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| LCB01-0371 Tablet 800 mg(T) | Drug | Test: taken drug after meal |
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