Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGBuprenorphine
Sponsors
Danish University of Pharmaceutical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
healthy 18-40 years able to follow the protocol able to provide informed consent
Exclusion criteria
* Allergy to buprenorphine * Mental illness * Alcohol or drug abuse * Chronic pain * Daily use of analgesics * Chronic medicinal treatment * Treatment with corticosteroids * Any use of medicine 48 hours before day of trial * Smoker * Blood donation within 3 months before day of trial * Dementia * Abnormal ECG * 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/
Countries
Denmark
Contacts
Primary ContactNiels-Henrik Jensen, MD
Backup ContactMette L Jensen, M Sc pharm
Outcome results
None listed