Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

This study is currently recruiting participants.

Verified by Danish University of Pharmaceutical Sciences, June 2006

Sponsored by:	Danish University of Pharmaceutical Sciences
Information provided by:	Danish University of Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00347815

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 I

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers

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

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

Study placed in the following topic categories:

Buprenorphine
Healthy

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics

Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 14, 2009