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Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary
• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCB01-0371 200mg | Experimental | LCB01-0371 IV 200 mg |
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| LCB01-0371 400mg | Experimental | LCB01-0371 IV 400 mg |
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| LCB01-0371 800mg | Experimental | LCB01-0371 IV 800 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCB01-0371 | Drug | Cohort1 & 3: Placebo-controlled, Single ascending dose administration |
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| Measure | Description | Time Frame |
|---|---|---|
| To assess Peak Plasma Concentration(Cmax) of LCB01-0371 | through study completion per patient, an average of 8 days (+ - 1 D) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bae KS | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30559004 | Derived | Cho YS, Lim HS, Han S, Yoon SK, Kim H, Cho YL, Nam HS, Bae KS. Single-dose Intravenous Safety, Tolerability, and Pharmacokinetics and Absolute Bioavailability of LCB01-0371. Clin Ther. 2019 Jan;41(1):92-106. doi: 10.1016/j.clinthera.2018.11.009. Epub 2018 Dec 15. |
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| ID | Term |
|---|---|
| C000627008 | delpazolid |
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| LCB01-0371 400mg | Drug | Cohort 2: Crossover designed administration |
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