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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

Page last updated: August 23, 2015

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