Status:
UNKNOWN
Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
Lead Sponsor:
Danish University of Pharmaceutical Sciences
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-40 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- healthy 18-40 years able to follow the protocol able to provide informed consent
Exclusion
- 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/
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00347815
Start Date
June 1 2006
End Date
August 1 2006
Last Update
July 4 2006
Active Locations (1)
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1
Gentofte University Hospital
Hellerup, Denmark, DK-2900