Healthy volunteers
Conditions
Interventions
Trade Name: Rimapen
Product Name: Rimapen
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Temgesic
Product Name: Te
Sponsors
Turku University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is aimed to examine the possible interactions of sublingual and intravenous buprenorphine with rifampicin;Secondary Objective: Not applicable;Primary end point(s): On day 7, a forearm vein will be cannulated with a plastic cannula for blood sampling. Timed venous blood samples will be drawn before the administration of buprenorphine and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18-20 hours after administration;Timepoint(s) of evaluation of this end point: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 18-20 hours after administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The psychomotor effects of buprenorphine will be assessed with visual analogue scales (Bond and Lader 1974) and digit symbol substitution test (Stone 1984) at 1?2 hour intervals up to 12 hours after buprenorphine administration. Visual analogue scales will be used for the following items: alert / drowsy, good / poor performance, no / strong drug effect, unpleasant / pleasant feeling, no / extreme nausea. For each pharmacodynamic variable, the area under the response-time curve will be determined by trapezoidal rule for 12 hours. The analgesic effect of buprenorphine will be evaluated using the cold pressor test. The cold pain test has been shown to be sensitive to opioid analgesia, and it enables repeated assessments of cold pain threshold, tolerance, intensity and unpleasantness (Grach et al. 2004). Briefly, the hand contra lateral to the venous cannula for blood sampling is immersed into ice-cold water of + 4º C up to the wrist. The subject is told to keep his or her hand in the water and to report when the cold sensation becomes painful. ;Timepoint(s) of evaluation of this end point: On day 7 prior to the challenge dose of buprenorphine and after the venous blood samples at 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after the challenge dose. | — |
Countries
Finland
Contacts
Public ContactTYKS/ATEK
Turku University Hospital
Outcome results
None listed