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

NCT06813807 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

0.5% TM

From D1 to D10, each subject will receive one drop of 0.5% timolol maleate ophthalmic gel forming solution each in the left and right eyes once daily at the same time every day under fasted condition.

Sponsors & Collaborators

  • Auson Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-15
Primary Completion
2024-07-05
Completion
2024-07-05
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06813807 on ClinicalTrials.gov