drugset / Trial / NCT00879099
Interaction Study of Timolol Eye Drops and Paroxetine Capsules
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2009-04
- Primary completion
- 2010-01
- Completion
- 2010-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Paroxetine | Small molecule | 20 mg | Oral |
| Subject | Timolol | Other / unclassified | 0.1 % | Other |
| Subject | Timolol | Other / unclassified | 0.5 % | Other |
Indications
No indication recorded.