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This study is a phase I clinical trial for evaluating the pharmacokinetics and safety/tolerability of DA-7218 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [Group 1] DA-7218 | Experimental | 200mg, By mouth or orally (PO) & intravenous(IV) administration |
|
| [Group 1] Placebo | Placebo Comparator | Placebo, By mouth or orally (PO) & intravenous(IV) administration |
|
| [Group 2] DA-7218 | Experimental | 400mg, By mouth or orally (PO) administration |
|
| [Group 2] Placebo | Placebo Comparator | Placebo, By mouth or orally (PO) administration |
|
| [Group 3] DA-7218 | Experimental | 600mg, By mouth or orally (PO) administration |
|
| [Group 3] Placebo | Placebo Comparator | Placebo, By mouth or orally (PO) administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DA-7218 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast | Area under the concentration-time curve from time zero to the last quantifiable concentration by linear trapezoidal method | 72 hours |
| Cmax | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| tmax, AUCinf, t1/2, CL/F, Vz/F (F; calculated in group 1) | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (subjective or objective symptoms) | 14 days(group 1), 7 days(group 2,3) | |
| Vital signs | 14 days(group 1), 7 days(group 2,3) | |
| Physical examination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung Sang Yu, M.D., Ph.D. | Seoul National University College of Medicine / Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28865799 | Derived | Kim Y, Kim A, Lee S, Choi SH, Lee DY, Song JS, Lee H, Jang IJ, Yu KS. Pharmacokinetics, Safety, and Tolerability of Tedizolid Phosphate After Single-dose Administration in Healthy Korean Male Subjects. Clin Ther. 2017 Sep;39(9):1849-1857. doi: 10.1016/j.clinthera.2017.08.002. Epub 2017 Aug 31. |
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| ID | Term |
|---|---|
| C515040 | tedizolid phosphate |
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| Drug |
|
| 14 days(group 1), 7 days(group 2,3) |
| 12-lead ECG | 14 days(group 1), 7 days(group 2,3) |
| Clinical laboratory tests | 14 days(group 1), 7 days(group 2,3) |