NCT00879099

Interaction Study of Timolol Eye Drops and Paroxetine Capsules

The Effect of Paroxetine on the Plasma Levels of Timolol Using Ophthalmic 0.5% Timolol Eye Drops and 0.1% Timolol Eye Gel in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Santen Oy · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2009-04-09
• Last updated: 2010-01-28

Locations

1 site across 1 country: Finland