drugset / Trial / NCT06813807

A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel With Timolol Maleate Gel

NCT06813807

Phase 1 Completed 18 enrolled Auson Pharmaceuticals Inc.
NaSingle-groupOpen-labelOther

Summary

The goal of this clinical trial is: 1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects. The main questions aim to answer are: * Pharmacokinetic (PK) profiles of healthy adult subjects * Safety Evaluation * To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.

Timeline

Start
2024-06-15
Primary completion
2024-07-05
Completion
2024-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Timolol Other / unclassified 0.5 % Other

Indications

No indication recorded.