Healthy Clinical Trial
Official title:
Effects of Rifampicin on the Pharmacokinetics and Pharmacodynamics of Sublingual and Intravenous Buprenorphine: A Four-phase Cross-over Study in Healthy Subjects.
Verified date | November 2014 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
This study is aimed to examine the possible interactions of sublingual and intravenous buprenorphine with rifampicin.
Status | Completed |
Enrollment | 12 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 40 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of buprenorphine and its metabolites in plasma and urine concebtration of buprenorphine | 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 and 20 hours after administration of buprenorphine | Yes | |
Secondary | Pharmacodynamic effects | The psychomotor effects on bubrenorphine will be assessed with the measurement of pupil size, Maddox wing test and symbol substitution test. | 1, 2,3, 4, 5, 6, 8, 10, 12, 20 hours after administration of buprenorphine | No |
Secondary | Analgesia | 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 | 1, 2, 3, 4, 5, 6, 8, 10, 12 hours after the administration of buprenorphine | No |
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