Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sublingual and Intravenous Buprenorphine
NCT ID: NCT01854489
Last Updated: 2014-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
12 participants
INTERVENTIONAL
2013-04-30
2014-11-30
Brief Summary
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Detailed Description
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Buprenorphine undergoes extensive first-pass metabolism and has low oral bioavailability of 15 %. Bioavailability following sublingual administration of buprenorphine is higher, 50-60 %. After high sublingual doses of buprenorphine (8-24 mg), peak plasma concentrations are reached in 1 hour and after low sublingual doses (0.4 mg) they are reached in approximately 3 h. Approximately two-thirds of a buprenorphine dose is excreted unchanged, and the rest is metabolized in the liver and intestinal wall. N-dealkylation of buprenorphine mainly via CYP3A but also CYP2C8 yields norbuprenorphine, and glucuronidation yields buprenorphine-3-glucuronide. Norbuprenorphine is excreted in the urine after subsequent conjugation. 80-90 % of buprenorphine is excreted by the biliary system and enterohepatic circulation.Although few interaction studies of high-dose buprenorphine and antiretrovirals have been conducted, the effect of CYP3A inducers on the pharmacokinetics of low-dose buprenorphine is unknown. Because the use of buprenorphine in pain management is increasing after the introduction of transdermal buprenorphin patches to the market, it is clinically relevant to study and quantify possible interactions of buprenorphine with inducers of its CYP3A-mediated metabolism such as rifampicin.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Rifampicin
The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days
Rifampicin
The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days
Placebo
The volunteers will be given oral placebo at 20.00 for 7 days
Placebo
The volunteers will be given Oral placebo at 20.00 for 7 days \[Phase 1 \]
Buprenorphine
The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.
Buprenorphine
The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.
Interventions
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Placebo
The volunteers will be given Oral placebo at 20.00 for 7 days \[Phase 1 \]
Rifampicin
The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days
Buprenorphine
The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18-40 years
* body weights within ±15% of the ideal weight for height
Exclusion Criteria
* Concomitant drug therapy of any kind for at least 14 days prior to the study.
* Subjects younger than 18 years and older than 40 years.
* Existing or recent significant disease.
* History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders.
* History of asthma or any kind of drug allergy.
* 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.
* A positive test result for urine toxicology.
* A "yes" answer to any one of the Abuse Questions.
* Pregnancy or nursing.
* Donation of blood for 4 weeks prior and during the study.
* Special diet or life style conditions which would compromise the conditions of the study or interpretation of the results.
* Participation in any other studies involving investigational or marketed drug products concomitantly or within one month prior to the entry into this study.
* Smoking for one month before the start of the study and during the whole study period.
18 Years
40 Years
ALL
Yes
Sponsors
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Turku University Hospital
OTHER_GOV
Responsible Party
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Mari Fihlman
MD
Locations
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Turku University Hospital
Turku, , Finland
Countries
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Other Identifiers
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Rifabupre
Identifier Type: -
Identifier Source: org_study_id