Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Buprenorphine After Intravenous Administration in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00347815
• Other study ID #: PROT-001-ML
• Status: Recruiting
• Phase: Phase 1
• First received: July 3, 2006
• Last updated: July 3, 2006
• Start date: June 2006
• Est. completion date: August 2006

Study information

• Verified date: June 2006
• Source: Danish University of Pharmaceutical Sciences
• Contact: Niels-Henrik Jensen, MD
• Phone: 004544884623
• Email: nije[@]herlevhosp.kbhamt.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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/

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Buprenorphine

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Danish University of Pharmaceutical Sciences

Country where clinical trial is conducted

Denmark,