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| Name | Class |
|---|---|
| Clinartis | INDUSTRY |
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This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCK 2349 | Experimental | Subjects will receive oral doses of WCK 2349 administered twice-daily for five days starting on Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WCK-2349 | Drug | Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM) | Determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Steady-state plasma pharmacokinetics of levonadifloxacin | To compare the steady-state plasma pharmacokinetics of levonadifloxacin following administration of WCK 2349 | 5 days |
| Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark H Gotfried, MD | Pulmonary Associates, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates, 1112 E. McDowell Rd. | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29263070 | Derived | Rodvold KA, Gotfried MH, Chugh R, Gupta M, Yeole R, Patel A, Bhatia A. Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02297-17. doi: 10.1128/AAC.02297-17. Print 2018 Mar. |
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| 14 days |