NCT03617510

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

A Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-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: 48 (actual)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · 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 3. To provide the basis for the dose for the follow-up clinical study.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Felbinac Trometamol Injection	Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours. It means the drug was given 3 times on D3 and D4,once on D5.
DRUG	Placebos	Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.

Timeline

• Start date: 2018-07-10
• Primary completion: 2018-11-05
• Completion: 2019-04-30
• First posted: 2018-08-06
• Last updated: 2020-07-02

Locations

1 site across 1 country: China