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Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00347815
Recruitment Status : Unknown
Verified June 2006 by Danish University of Pharmaceutical Sciences.
Recruitment status was:  Recruiting
First Posted : July 4, 2006
Last Update Posted : July 4, 2006
Sponsor:
Information provided by:
Danish University of Pharmaceutical Sciences

Tracking Information
First Submitted Date  ICMJE July 3, 2006
First Posted Date  ICMJE July 4, 2006
Last Update Posted Date July 4, 2006
Study Start Date  ICMJE June 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers
Official Title  ICMJE Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: Buprenorphine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: July¬†3,¬†2006)
24
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE August 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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/

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00347815
Other Study ID Numbers  ICMJE PROT-001-ML
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Danish University of Pharmaceutical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Niels-Henrik Jensen, MD Multidisciplinary Pain Centre, Herlev Hospital
PRS Account Danish University of Pharmaceutical Sciences
Verification Date June 2006

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