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Interaction Study of Timolol Eye Drops and Paroxetine Capsules

This study has been completed.
Sponsor:
Information provided by:
Santen Oy
ClinicalTrials.gov Identifier:
NCT00879099
First received: April 7, 2009
Last updated: January 27, 2010
Last verified: July 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: Paroxetine
Drug: Placebo
Drug: timolol maleate
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources

Further study details as provided by Santen Oy:

Primary Outcome Measures:
  • The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax). [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Paroxetine Drug: Paroxetine
Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days.
Placebo Comparator: Gelatine capsule Drug: Placebo
Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days.
Experimental: Timolol 0.5 % eye drops
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
 Drug: 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.
Experimental: Timosan 0.1% eye gel
The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes.
 Drug: 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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879099

Locations
Finland
University of Helsinki, Department of Clinical Pharmacology
Helsinki, Biomedicum, Finland, 00014
Sponsors and Collaborators
Santen Oy
Investigators
Principal Investigator: Janne Backman, MD, PhD Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki
  More Information

No publications provided

Responsible Party: Auli Ropo, Study director
ClinicalTrials.gov Identifier: NCT00879099     History of Changes
Other Study ID Numbers: 73654, Eudra CT 2008-007324-26
Study First Received: April 7, 2009
Last Updated: January 27, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Santen Oy:
Interaction
healthy volunteers
Interaction study for healthy volunteers

Additional relevant MeSH terms:
Timolol
Tetrahydrozoline
Paroxetine
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
 Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Enzyme Inhibitors
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013