Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
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|ClinicalTrials.gov Identifier: NCT00969852|
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Sertraline||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||[11C] Sertraline PET Imaging Study That Investigates Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||March 2010|
Multiple doses of 5, 25, and 50 mg Sertraline for 6 days each period.
Other Name: Zoloft(Pfizer)
- Serotonin receptor occupancy [ Time Frame: Day -1, Day 7, Day 14, Day 21 ]
- Plasma concentration of sertraline [ Time Frame: Day 4, 5, 6, 7, 11, 12, 13, 14, 18, 19, 20, 21 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|