Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

July 3, 2006 updated by: Danish University of Pharmaceutical Sciences

Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Mette L Jensen, M Sc Pharm
  • Phone Number: 004561676954
  • Email: mlj@dfuni.dk

Study Locations

  • Denmark
      • Hellerup, Denmark, DK-2900
        • Recruiting
        • Gentofte University Hospital
        • Contact:
          • Mette L Jensen, M Sc Pharm
          • Phone Number: 004561676954
          • Email: mlj@dfuni.dk
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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/

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish University of Pharmaceutical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

August 1, 2006

Study Registration Dates

First Submitted

July 3, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

July 3, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT-001-ML

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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