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To investigate pharmacokinetics, safety and tolerability of LCB01-0371, LCB01-0371-B after a single oral dose in healthy male subjects.
To investigate safety, tolerability of LCB01-0371 after a single oral dose in healthy male subjects.
An Open-label, Single dose, Parallel design, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Oral dosage form of LCB01-0371 in Healthy Male Volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: LCB01-0371 | Experimental | Period 1: LCB01-0371 Tablet 400 mg Period 2: LCB01-0371 Tablet 400 mg |
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| Group 2: LCB01-0371 | Experimental | Period 1: LCB01-0371 Tablet 800 mg Period 2: LCB01-0371 Tablet 1200 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group 1:LCB01-0371 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Peak Plasma Concentration (Cmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours | |
| Pharmacokinetics: time to maximum concentration (Tmax) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours | |
| Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) | 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Event | participants will be followed after hospital stay, an expected average of 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyun-Seop Bae, MD PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| Group 2:LCB01-0371 | Drug |
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