Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
NCT ID: NCT00347815
Last Updated: 2006-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
24 participants
INTERVENTIONAL
2006-06-30
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Buprenorphine
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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/
18 Years
40 Years
MALE
Yes
Sponsors
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Danish University of Pharmaceutical Sciences
OTHER
Principal Investigators
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Niels-Henrik Jensen, MD
Role: PRINCIPAL_INVESTIGATOR
Multidisciplinary Pain Centre, Herlev Hospital
Locations
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Gentofte University Hospital
Hellerup, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Jesper Sonne, MD
Role: primary
Mette L Jensen, M Sc Pharm
Role: backup
Other Identifiers
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PROT-001-ML
Identifier Type: -
Identifier Source: org_study_id