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Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Sponsor
Danish University of Pharmaceutical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00347815
Collaborator
(none)
24
Enrollment
1
Location
2
Duration (Months)
12
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers
Study Start Date :
Jun 1, 2006
Study Completion Date :
Aug 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Male
    Accepts 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/

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gentofte University Hospital Hellerup Denmark DK-2900

    Sponsors and Collaborators

    • Danish University of Pharmaceutical Sciences

    Investigators

    • Principal Investigator: Niels-Henrik Jensen, MD, Multidisciplinary Pain Centre, Herlev Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00347815
    Other Study ID Numbers:
    • PROT-001-ML
    First Posted:
    Jul 4, 2006
    Last Update Posted:
    Jul 4, 2006
    Last Verified:
    Jun 1, 2006
    Additional relevant MeSH terms:
    Buprenorphine

    Study Results

    No Results Posted as of Jul 4, 2006