Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Health, Welfare and Family Affairs
Korea National Enterprise for Clinical Trials
Conditions:
Healthy
Eligibility:
MALE
20-50 years
Phase:
PHASE4
Brief Summary
This study aimed to explore the pharmacokinetics and pharmacodynamics of low dose sertraline with \[11C\] sertraline positron emission tomography (PET) study.
Detailed 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 Subj...
Eligibility Criteria
Inclusion
- Age: Between 20 to 50 years of age, inclusive (age based on the date to give the informed consent)
- Weight: Over 55 kg, within ±20% of ideal body weight
- Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily
Exclusion
- History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease
- History of a significant surgical resection of gastrointestinal tract except appendectomy
- Abnormal clinical laboratory findings, especially for AST or ALT \> 1.25 fold of upper normal limit
- Subject who has phobia for PET scan
- History or evidence of drug abuse
- Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (If used medication is considered acceptable by investigator, patients can be included)
- Participation in clinical trials of any drug within 2 months prior to the participation of the study
- Donation of whole blood within 2 months or a unit of blood within 1 month prior to the start of study
- Judged to be inappropriate for the study by the investigator
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00969852
Start Date
July 1 2009
End Date
March 1 2010
Last Update
January 11 2011
Active Locations (1)
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1
Clinical Trials Center, Seoul National University Hospital
Seoul, South Korea, 110-744