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| ID | Type | Description | Link |
|---|---|---|---|
| Eudra CT 2008-007324-26 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Active Comparator |
| |
| Gelatine capsule | Placebo Comparator |
| |
| Timolol 0.5 % eye drops | Experimental | The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes. |
|
| Timosan 0.1% eye gel | Experimental | The plasm levels of timolol will be measured after one drop of timolol has been administered into both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Paroxetine 20 mg once a day during two treatment periods. One treatment period lasts for 3 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary parameters will be timolol area under the plasma drug concentration-time curve (AUC0-12h) and highest drug concentration observed in plasma (Cmax). | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janne Backman, MD, PhD | Department of Clinica Pharmacology, Institute of Clinical Medicine, University of Helsinki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Helsinki, Department of Clinical Pharmacology | Helsinki | Biomedicum | 00014 | Finland |
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| ID | Term |
|---|---|
| D017374 | Paroxetine |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011412 | Propanolamines |
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| Placebo | Drug | Gelatine capsule once a day during two treatment periods. One treatment period lasts for 3 days. |
|
| timolol maleate | Drug | 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 | Drug | Timosan 0,1 % eye gel. One drop into both eyes on day 3 after taking paroxetine or placebo capsules for three days. |
|
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D009025 | Morpholines |
| D010078 | Oxazines |