Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Danish University of Pharmaceutical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00347815
First received: July 3, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted

July 3, 2006
July 3, 2006
June 2006
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No Changes Posted
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Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy Volunteers
Drug: Buprenorphine
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
August 2006
Not Provided

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/

Male
18 Years to 40 Years
Yes
Contact: Niels-Henrik Jensen, MD 004544884623 nije@herlevhosp.kbhamt.dk
Contact: Mette L Jensen, M Sc pharm 004561676954 mlj@dfuni.dk
Denmark
 
NCT00347815
PROT-001-ML
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Danish University of Pharmaceutical Sciences
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Principal Investigator: Niels-Henrik Jensen, MD Multidisciplinary Pain Centre, Herlev Hospital
Danish University of Pharmaceutical Sciences
June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP