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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. 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
Information provided by:
Danish University of Pharmaceutical Sciences

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
Healthy Volunteers Drug: Buprenorphine Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
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 : June 2006
Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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/

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00347815

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Contact: Niels-Henrik Jensen, MD 004544884623
Contact: Mette L Jensen, M Sc pharm 004561676954

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Gentofte University Hospital Recruiting
Hellerup, Denmark, DK-2900
Contact: Jesper Sonne, MD    004539773477   
Contact: Mette L Jensen, M Sc Pharm    004561676954   
Sponsors and Collaborators
Danish University of Pharmaceutical Sciences
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Principal Investigator: Niels-Henrik Jensen, MD Multidisciplinary Pain Centre, Herlev Hospital
Layout table for additonal information Identifier: NCT00347815    
Other Study ID Numbers: PROT-001-ML
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: July 4, 2006
Last Verified: June 2006
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists