Status:
COMPLETED
Interaction Study of Timolol Eye Drops and Paroxetine Capsules
Lead Sponsor:
Santen Oy
Conditions:
Healthy
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00879099
Start Date
April 1 2009
End Date
January 1 2010
Last Update
January 28 2010
Active Locations (1)
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1
University of Helsinki, Department of Clinical Pharmacology
Helsinki, Biomedicum, Finland, 00014