Interaction Study of Timolol Eye Drops and Paroxetine Capsules

S

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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