Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy Volunteers

Danish University of Pharmaceutical Sciences

Status and phase

Unknown

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Buprenorphine

Study type

Interventional

Funder types

Other

Identifiers

NCT00347815

PROT-001-ML

Details and patient eligibility

About

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.

Sex

Male

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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/