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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
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers

Resource links provided by NLM:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00347815     History of Changes
Other Study ID Numbers: PROT-001-ML
Study First Received: July 3, 2006
Last Updated: July 3, 2006
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013