Effects of rifampicin on the pharmacokinetics and pharmacodynamics of sublingual and intravenous buprenorphine

Conditions: Healthy volunteers
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-002871-32-FI

Lead Sponsor: Turku University hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Twelve male or female adult non-smoking subjects aged 18?40 years with body weights within ±15% of the ideal weight for height will be recruited for the study. The subjects will be submitted to physical examination, determination of previous or present chronic diseases, and comprehensive laboratory testing to ascertain that they are in good health. The subjects will fill in a modified Finnish version of the Abuse Questions (Michna et al. 2004) to assess their vulnerability for opioid abuse. Laboratory screening will include CBC (including hemoglobin, hematocrit, differential WBC, platelet count), SGOT, SGPT, alkaline phosphatase, BUN and creatinine, and for women a pregnancy test. Urine will be screened for glucose, proteins and drugs with addiction potential. Blood pressure in sitting position must be within normal limits. Base line ECG must be normal.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.A previous history of intolerance to the study drugs or to related compounds and additives.
2.Concomitant drug therapy of any kind for at least 14 days prior to the study.
3.Subjects younger than 18 years and older than 40 years.
4.Existing or recent significant disease.
5.History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders.
6.History of asthma or any kind of drug allergy.
7.Previous or present alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
8.A positive test result for urine toxicology.
9.A yes” answer to any one of the Abuse Questions.
10.Pregnancy or nursing.
11.Donation of blood for 4 weeks prior and during the study.
12.Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results.
13.Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
14.Smoking for one month before the start of the study and during the whole study period.