None listed
Conditions
Interventions
Trade Name: Temgesic
Pharmaceutical Form: Soluble tablet
INN or Proposed INN: BUPRENORPHINE
CAS Number: 52485-79-7
Trade Name: Noxafil
Product Code: J02AC04
Pharmaceutical Form: Oral suspension
INN o
Sponsors
Derartment of Anaesthesiology and Intensive Care, Turku University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Twelve male or female adult non-smoking subjects in good health aged 18-40 years with body weights within ±15% of the ideal weight for height will be recruited for the study. The subjects will fill in a modified Finnish version of the Abuse Questions 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. Subjects should not have taken any drugs or natural products, excluding alcohol, for at least 14 days prior to the study and no drugs known to cause enzyme induction or inhibition or grapefruit juice for a period of 30 days prior to the study. For women of childbearing age, safe nonhormonal contraception must be ensured. Subjects must give written informed consent. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Criteria for exclusion 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 low-dose sublingual buprenorphine with posaconazole and voriconazole.;Secondary Objective: ;Primary end point(s): Pharmacokinetic and pharmacodynamic measurements Pharmacokinetics: 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. Urine will be collected for 18-20 hours. Buprenorphine, norbuprenorphine, buprenorphine-3-glucuronide and norbuprenorphine-3-glucuronide concentrations will be analyzed with chromatographical methods. The urinary excretion of buprenorphine and its metabolites will be measured. For the control of compliance, plasma posaconazole and voriconazole concentrations will be measured before the administration of buprenorphine. The plasma pharmacokinetics of buprenorphine and its metabolites will be characterized by area under the drug plasma concentration-time curve (AUC0-8), calculated using the trapezoidal rule. Elimination half-lives (T½), peak concentrations (Cmax) and concentration peak times (Tmax) will be calculated. Pharmacodynamics: The psychomotor effects of buprenorphine will be assessed with visual analog scales and digit symbol substitution test 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. Possible adverse effects: All volunteered and observed adverse effects will be recorded together with the time at which the effect was noted, its severity, duration and treatment. | — |
Countries
Finland
Outcome results
None listed