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Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Intravenous WCK 771
The present study is planned to assess the safety and pharmacokinetic profile in normal healthy subjects in US for WCK 771 with doses ranging from 600 mg to 1000 mg BID for 5 days. In the proposed Phase I MAD study, a subject will be administered 600mg, 800mg, and 1000mg WCK 771 BID for 5 days (Ten doses) or an identical placebo as intravenous infusion.
Details
| Lead sponsor | Wockhardt |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | Thu Dec 01 2011 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Wed Jun 27 2012 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Bioavailability
Interventions
- WCK 771 IV Infusion
- Placebo IV Infusion
Countries
United States