Safety, Tolerability and Pharmacokinetics of Felbinac Trometamol Eye Drops — Binaprofen  

Healthy Clinical Trial

Official title: A Phase I Study to the Safety, Tolerability, and Pharmacokinetic Characteristics of Felbinac Trometamol Eye Drops of Single-dose and Multiple-dose in Healthy Subjects

Status Recruiting

Clinical Trial Summary

To evaluate the safety and tolerability of felbinac trometamol eye drops of single-dose, multiple-dose, dose escalation in healthy subjects, for providing the basis for the dose setting in the later clinical study.

Clinical Trial Description

In the single-center, randomized, double-blind, placebo-controlled, single-dose dose escalation study, 48 healthy volunteers will be divided from low dose to high dose into 5 single-dose groups of 0.025%, 0.05%, 0.1%, 0.2% and 0.3%, with both male and female subjects in each group. The study was designed as double-blind, all the single-dose groups containing 10 subjects except the single-dose group of 0.025% containing 8 subjects，and with 2 placebo controls in each group.

Pharmacokinetics blood sampling in different dose groups was designed from low dose to high dose into 4 single-dose groups of 0.05%, 0.1%, 0.2% and 0.3%.

In the single-center, randomized, double-blind, placebo-controlled, multiple-dose dose escalation study, 20 healthy volunteers will be divided into low dose and high dose groups of 0.1% and 0.2%, with both male and female subjects in each group. The study was designed as double-blind, all the dose groups containing 8 subjects and 2 placebo controls. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05085106
• Study type: Interventional
• Source: Beijing Tongren Hospital
• Contact: Feng Wu, Ph.D.
• Phone: 010-58268422
• Email: trdrug@126.com
• Status: Recruiting
• Phase: Phase 1
• Start date: October 21, 2020
• Completion date: December 31, 2021