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Systemic Pharmacokinetic Study of T4032 (Unpreserved Bimatoprost 0.01%) Eye Gel Versus Lumigan® 0.01% Eye Drops in 40 Healthy Volunteers

NCT05729594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-14

No results posted yet for this study

Summary

This study is being performed to compare the systemic pharmacokinetic profiles of T4032 and Lumigan 0.01% given that T4032 has a different formulation (in terms of excipients) from the reference product.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Bimatoprost Ophthalmic

eyedrops

Sponsors & Collaborators

  • Laboratoires Thea

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-27
Primary Completion
2023-04-05
Completion
2023-04-05
FDA Drug
Yes

Countries

  • United States

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 NCT05729594 on ClinicalTrials.gov