NCT03235778

A Phase I Clinical Study Trial of Felbinac Trometamol Injection in China

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase I Clinical Study Trial to Evaluate the Tolerance and Pharmacokinetics of Felbinac Trometamol Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Yiling Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

1. To evaluate the tolerances of healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose 2. To evaluate the pharmacokinetic characteristics in healthy subjects treated with Felbinac Trometamol Injection on multiple dose and single dose

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Felbinac Trometamol Injection	Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
DRUG	Placebo	Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump

Timeline

• Start date: 2017-07-17
• Primary completion: 2018-03-19
• Completion: 2018-06-15
• First posted: 2017-08-01
• Last updated: 2019-11-18

Locations

1 site across 1 country: China