Impact of Celecoxib on Electrophysiological Property in Brain of Healthy Volunteer

• Status: Completed
• Trial end date: 2017-04-28
• Target enrollment: 0
• Participant gender: All

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 alteration in brain cortex by long-term treatment of celecoxib (200mg twice-daily for 7 days) in healthy volunteer

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul National University Hospital
• Treatments: Celecoxib; Cyclooxygenase 2 Inhibitors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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