drugset / Trial / NCT06824948

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

NCT06824948

Phase 1 Completed 28 enrolled Auson Pharmaceuticals Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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, λz, 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.

Timeline

Start
2018-10-12
Primary completion
2018-12-12
Completion
2018-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Timolol Other / unclassified 0.5 % Topical

Indications

No indication recorded.