Pharmacokinetics of Tasimelteon Alone and in Combination With CYP1A2 Inhibitor, Fluvoxamine
The purpose of this research study is to evaluate whether administration of a CYP1A2 inhibitor affects the single-dose pharmacokinetics of tasimelteon and its metabolites. The safety and tolerability of tasimelteon will also be assessed throughout the study.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Bio-Kinetic Clinical Applications
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01540500
- Information obtained from ClinicalTrials.gov on May 08, 2012
Medical and Biotech [MESH] Definitions
A selective serotonin reuptake inhibitor. It is effective in the treatment of depression, obsessive-compulsive disorders, anxiety, panic disorders, and alcohol amnestic disorders.
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Patient Escort Service
A special service provided by volunteers to accompany patients who need help in moving about the health facility.
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Clinical Trial, Phase Ii
Work that is a report of a pre-planned, usually controlled, clinical study of the safety and efficacy of diagnostic, therapeutic, or prophylactic drugs, devices, or techniques based on several hundred volunteers, including a limited number of patients, and conducted over a period of about two years in either the United States or a foreign country.
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