Effects of posaconazole and voriconazole on the pharmacokinetics and pharmacodynamics of sublingual buprenorphine: A three-phase double-blind cross-over study in healthy subjects.

Conditions: - healty volunteer subjects- The study is aimed to examine the possible interactions of low-dose sublingual buprenorphine with posaconazole and voriconazole.

Registration Number: EUCTR2010-020953-14-FI

Lead Sponsor: Derartment of Anaesthesiology and Intensive Care, 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: 12

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

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.