NCT03622008

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

A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Antibiotics Causing Adverse Effects in Therapeutic Use

Interventions

Type	Name	Description
DRUG	FEP-TAZ 4 g	FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days
OTHER	Placebo	Placebo IV

Timeline

• Start date: 2018-03-23
• Primary completion: 2018-05-13
• Completion: 2018-05-30
• First posted: 2018-08-09
• Last updated: 2018-08-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study