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Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

2014-08-27 03:19:37 | BioPortfolio

Summary

This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with [11C] sertraline positron emission tomography (PET) study.

Description

Open, one arm, single sequence, 3-period, dose escalating study for healthy volunteers are investigated. Ten subjects may be enrolled.

Subjects receive baseline [11C] sertraline PET.

Period 1 Subjects receive 5 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Period 2 Subjects receive 25 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Period 3 Subjects receive 50 mg of sertraline every day. After 6 day of medication, pharmacokinetic and PET studies are performed.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Sertraline

Location

Clinical Trials Center, Seoul National University Hospital
Seoul
Korea, Republic of
110-744

Status

Recruiting

Source

Seoul National University Hospital

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:19:37-0400

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