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Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

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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:

Study Description
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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT00347815


Contacts
Contact: Niels-Henrik Jensen, MD 004544884623 nije@herlevhosp.kbhamt.dk
Contact: Mette L Jensen, M Sc pharm 004561676954 mlj@dfuni.dk

Locations
Denmark
Gentofte University Hospital Recruiting
Hellerup, Denmark, DK-2900
Contact: Jesper Sonne, MD    004539773477    jeso@gentoftehosp.kbhamt.dk   
Contact: Mette L Jensen, M Sc Pharm    004561676954    mlj@dfuni.dk   
Sponsors and Collaborators
Danish University of Pharmaceutical Sciences
Investigators
Principal Investigator: Niels-Henrik Jensen, MD Multidisciplinary Pain Centre, Herlev Hospital
More Information

ClinicalTrials.gov Identifier: NCT00347815     History of Changes
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:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists