MedTrace Logo

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

NCT06824948 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

Timolol Maleate Gel

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel one time a day during Day 3-Day 12.

DRUG

Placebo

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo one time a day during Day 3-Day 12.

DRUG

Timolol Maleate Gel

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 2 times a day during Day 3-Day 12.

DRUG

Placebo

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 2 times a day during Day 3-Day 12.

DRUG

Timolol Maleate Gel

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with 0.5% timolol maleate gel 3 times a day during Day 3-Day 12.

DRUG

Placebo

A 2-day washout phase follows 1 dose on Day 1, the subjects are applied with placebo 3 times a day during Day 3-Day 12.

Sponsors & Collaborators

  • Auson Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06824948 on ClinicalTrials.gov