Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sublingual and Intravenous Buprenorphine

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is aimed to examine the possible interactions of sublingual and intravenous buprenorphine with rifampicin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Turku University Hospital
• Treatments: Buprenorphine; Rifampin

Criteria

Inclusion Criteria:

• non-smoking

• aged 18-40 years

• body weights within ±15% of the ideal weight for height

Exclusion Criteria

• A previous history of intolerance to the study drugs or to related compounds and additives.

• 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.