Interaction Study of Timolol Eye Drops and Paroxetine Capsules
Information source: Santen Oy
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Paroxetine (Drug); Placebo (Drug); timolol maleate (Drug); timolol maleate (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Santen Oy Official(s) and/or principal investigator(s): Janne Backman, MD, PhD, Principal Investigator, Affiliation: Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax).
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
University of Helsinki, Department of Clinical Pharmacology, Helsinki, Biomedicum 00014, Finland
Additional Information
Starting date: April 2009
Last updated: January 27, 2010
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