drugset / Trial / NCT03622008

To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)

NCT03622008

Phase 1 Completed 20 enrolled Wockhardt Clinartis · collab
RandomizedParallel-groupQuadruple-blindBasic science

Summary

To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.

Timeline

Start
2018-03-23
Primary completion
2018-05-13
Completion
2018-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cefepime Small molecule 2 g Intravenous
Subject Tazobactam Small molecule 2 g Intravenous