Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||[11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration|
- Serotonin receptor occupancy [ Time Frame: Day -1, Day 7, Day 14, Day 21 ] [ Designated as safety issue: No ]
- Plasma concentration of sertraline [ Time Frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||March 2010|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other Name: Zoloft(Pfizer)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969852
|Korea, Republic of|
|Clinical Trials Center, Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Principal Investigator:||Kyung-Sang Yu, MD, PhD||Seoul National University College of Medicine and Hospital|