NCT02532140

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime

Phase I Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of WCK 5107 Alone and in Combination With Cefepime Administered as Single IV Doses in Healthy Human Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Wockhardt · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

• To evaluate the safety,tolerability and pharmacokinetics of single intravenous doses of WCK 5107 alone and in combination with cefepime in healthy adult human subjects.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	WCK 5107 250 mg to 2000 mg
DRUG	Cefepime 2000 mg
DRUG	WCK 5107 1000/2000 mg with Cefepime 2000 mg combination
DRUG	Placebo

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-08-25
• Last updated: 2016-05-03

Locations

1 site across 1 country: United States