Status:
COMPLETED
Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer
Lead Sponsor:
Seoul National University Hospital
Conditions:
Electrophysiologic Property of Brain
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
the purposes of this study are to evaluate the acute electrophysiological response in brain cortex to single oral dose of celecoxib (400mg once) in healthy volunteer and the electrophysiological alter...
Detailed Description
Inflammatory response is considered as defense mechanism against physical or infectious insults and also prevails within the central nervous system. Following certain kinds of brain injuries (i.e trau...
Eligibility Criteria
Inclusion
- Healthy male or female aged between 20 and 50 years.
- Signed voluntary written informed consent.
- Body mass index between 16.0 and 30.0 kg/m2.
Exclusion
- History of cardiovascular disease (i.e. Heart disease, Stroke), hepatic disease, inflammatory bowel disease, gastrointestinal hemorrhage, or seizure(s).
- History of hypersensitivity to any medication(s) (i.e. urticaria, angioedema, shock)
- History of any kind of medication(s) within 1 week before screening.
- Presence of clinically significant electrocardiogram abnormality at screening.
- aspartate transaminase or alanine transaminase : greater than 2.0 × upper normal limit.
- Serum creatinine levels : greater than 1.5 × upper normal limit.
- Platelet counts lower than 100,000 / μL
- Serum potassium : greater than 5.5 mmol/L
- Female who is pregnant, breastfeeding, or intends to become pregnant.
- History of noncompliance with medications.
- History of alcohol abuse.
- Participation in drug study within 30 days before screening.
- Galactose intolerance
Key Trial Info
Start Date :
May 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 28 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02711579
Start Date
May 1 2016
End Date
April 28 2017
Last Update
May 22 2017
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea