Interaction Study of Timolol Eye Drops and Paroxetine Capsules
NCT ID: NCT00879099
Last Updated: 2010-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2009-04-30
2010-01-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Paroxetine
Paroxetine
Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
Gelatine capsule
Placebo
Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
Timolol 0.5 % eye drops
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
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.
Timosan 0.1% eye gel
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
timolol maleate
Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
Interventions
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Paroxetine
Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
Placebo
Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
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.
timolol maleate
Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
40 Years
MALE
Yes
Sponsors
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Santen Oy
INDUSTRY
Responsible Party
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Study director
Principal Investigators
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Janne Backman, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
Locations
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University of Helsinki, Department of Clinical Pharmacology
Helsinki, Biomedicum, Finland
Countries
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Other Identifiers
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Eudra CT 2008-007324-26
Identifier Type: -
Identifier Source: secondary_id
73654
Identifier Type: -
Identifier Source: org_study_id