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The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WCK 2349 | Experimental | WCK 2349 800mg, 1000mg, and 1200mg . 1 dose given orally twice daily at 12 hourly interval for five days. Dosage form : Oral |
|
| Placebo | Placebo Comparator | Matching Placebo administered as Oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WCK 2349 Oral | Drug | 1 dose given orally twice daily at 12 hourly interval for five days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety & tolerability of multiple doses of WCK 2349 | By monitoring the adverse events reported | 12 days |
| To evaluate the pharmacokinetics of multiple doses of WCK 2349 | Measuring Cmax Maximum observed plasma concentration. | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashima Bhatia, MD | Wockhardt Ltd | Study Director |
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| ID | Term |
|---|---|
| C000706771 | levonadifloxacin |
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| Placebo Oral |
| Other |
Subjects will receive matching placebo |
|