Interaction Study of Timolol Eye Drops and Paroxetine Capsules

Sponsor

Santen Oy (Industry)

Overall Status

Completed

CT.gov ID

NCT00879099

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Paroxetine Drug: Placebo Drug: timolol maleate Drug: timolol maleate	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paroxetine	Drug: Paroxetine Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
Placebo Comparator: Gelatine capsule	Drug: Placebo Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
Experimental: Timolol 0.5 % eye drops The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.	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.
Experimental: Timosan 0.1% eye gel The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.	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.

Outcome Measures

Primary Outcome Measures

The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax). [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

male
18 - 40 years of age
be in good general health
be willing to follow instructions
provide a written informed consent
have a BMI of 18.5 - 26
have systolic blood pressure at least 105 mmHg
have haemoglobin at least 135 g/l.

Exclusion Criteria:

known hypersensitivity to timolol, paroxetine or any component of the study medications
any contraindications to timolol treatment including asthma and obstructive lung disease
any contraindications to paroxetine treatment
have heart rate 50/min or less in rest
any regular medication
allergy requiring antihistamine or ocular or nasal treatment
clinically significant abnormalities (from normal limits) in laboratory values: basic blood count, creatinine, ALAT, AFOS, gamma-GT, K, Na
clinically significant EKG abnormalities assessed by the investigator
blood donation within the last 60 days (the required time period between two donations for men given by RedCross Finland).
participation in another clinical trial involving an investigational drug/device, or participation in such trial within the last 60 days