Interaction Study of Timolol Eye Drops and Paroxetine Capsules

Santen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: timolol maleate; Drug: Placebo; Drug: Paroxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00879099

73654

Eudra CT 2008-007324-26

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 4 patient groups, including a placebo group

Paroxetine

Active Comparator group

Treatment:

Drug: Paroxetine

Gelatine capsule

Placebo Comparator group

Treatment:

Drug: Placebo

Timolol 0.5 % eye drops

Experimental group

Description:

The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.

Treatment:

Drug: timolol maleate

Timosan 0.1% eye gel

Experimental group

Description:

The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.

Treatment:

Drug: timolol maleate