Overview

Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel

Status:
COMPLETED
Trial end date:
2018-12-12
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to to evaluate the safety, tolerance, and pharmacokinetic profiles of Timolol Maleate Gel in healthy Chinese adult subjects. The main questions aim to answer are: The pharmacokinetic endpoints: Single dose:Tmax, Cmax, etc. Multiple doses:AUC0-t, AUC0-inf, z, t1/2, etc. The safety and tolerance endpoints: Physical examination, vital signs, 12-lead ECG, laboratory tests (hematology, blood biochemistry and urinalysis), adverse events, local tolerance. Researchers will compare TM gel to a placebo (a look-alike substance that contains no drug) to see if TM gel works to treat IH.
Phase:
PHASE1
Details
Lead Sponsor:
Auson Pharmaceuticals Inc.