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Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Danish University of Pharmaceutical Sciences.
Recruitment status was:  Recruiting
Information provided by:
Danish University of Pharmaceutical Sciences Identifier:
First received: July 3, 2006
Last updated: NA
Last verified: June 2006
History: No changes posted
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 Intervention Phase
Healthy Volunteers Drug: Buprenorphine Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Danish University of Pharmaceutical Sciences:

Estimated Enrollment: 24
Study Start Date: June 2006
Estimated Study Completion Date: August 2006

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/

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00347815

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

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
Principal Investigator: Niels-Henrik Jensen, MD Multidisciplinary Pain Centre, Herlev Hospital
  More Information Identifier: NCT00347815     History of Changes
Other Study ID Numbers: PROT-001-ML
Study First Received: July 3, 2006
Last Updated: July 3, 2006

Additional relevant MeSH terms:
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists processed this record on September 21, 2017