Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT00347815
Recruitment Status : Unknown
Verified June 2006 by Danish University of Pharmaceutical Sciences. Recruitment status was: Recruiting
The purpose of this study is to determine the amount of buprenorphine and its metabolites in blood and urine after administration of 0.6 mg buprenorphine in healthy volunteers. Furthermore the purpose is to correlate the amount of buprenorphine in the blood with the effect on the ability to concentrate and coordinate.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
healthy 18-40 years able to follow the protocol able to provide informed consent
Allergy to buprenorphine
Alcohol or drug abuse
Daily use of analgesics
Chronic medicinal treatment
Treatment with corticosteroids
Any use of medicine 48 hours before day of trial
Blood donation within 3 months before day of trial
Abnormal blood values:
Serum creatinine > 100 umol/l Serum haemoglobin < 8 mmol/L LDH < 105 U/L or > 255 U/L ASAT > 45 U/L ALAT > 70 U/L PP < 0.9 INR or > 1.1 INR Alkaline phosphatase < 35 U/L or > 275 U/L K+ < 3,5 mmol/L or > 5,0 mmol/L Na + < 136 mmol/L or > 146 mmol/