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Interaction Study of Timolol Eye Drops and Paroxetine Capsules

NCT00879099 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-01-28

No results posted yet for this study

Summary

The aim of the study is to investigate the effect of antidepressant paroxetine, on the plasma levels of timolol and its main metabolites after topical application of ophthalmic timolol products.

This will be a phase I, randomised, 4-phase cross-over study in healthy volunteers. Healthy male volunteers aged 18 - 40 years will be enrolled.

Placebo or paroxetine will be given for three days after which 1 drop of timolol product will be administered once in both eyes.

The duration of the paroxetine or placebo treatment period will be 3 days. There will be four different treatment periods. A washout between the study periods will be at least 4 weeks.

Conditions

  • Healthy

Interventions

DRUG

Paroxetine

Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.

DRUG

Placebo

Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.

DRUG

timolol maleate

Oftan Timolol 0,5 % eye drop. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.

DRUG

timolol maleate

Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.

Sponsors & Collaborators

  • Santen Oy

    lead INDUSTRY

Principal Investigators

  • Janne Backman, MD, PhD · Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Finland

Study Locations

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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 NCT00879099 on ClinicalTrials.gov