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

NCT01854489 | Completed Phase 4

• 1 other identifier: Rifabupre
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Buprenorphine; Rifampicin; Interactions; Pharmakokinetics; Pharmakodynamics

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Pharmacodynamic effects

  1, 2,3, 4, 5, 6, 8, 10, 12, 20 hours after administration of buprenorphine

• Analgesia

  1, 2, 3, 4, 5, 6, 8, 10, 12 hours after the administration of buprenorphine

Study Arms (3)

Rifampicin

ACTIVE COMPARATOR

The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days

Drug: Rifampicin

Placebo

PLACEBO COMPARATOR

The volunteers will be given oral placebo at 20.00 for 7 days

Drug: Placebo

Buprenorphine

ACTIVE COMPARATOR

The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.

Drug: Buprenorphine

Interventions

Placebo DRUG

The volunteers will be given Oral placebo at 20.00 for 7 days \[Phase 1 \]

Placebo

Rifampicin DRUG

The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days

Rifampicin

Buprenorphine DRUG

The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.

Also known as: Temgesic 0,2 mg resoriblet, Temgesic 0,3 mg/ml

Buprenorphine

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• non-smoking
• aged 18-40 years
• body weights within ±15% of the ideal weight for height

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku University Hospital

Turku, 20500, Finland

Location

MeSH Terms

Interventions

Rifampin; Buprenorphine

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 27, 2013
• First Posted: May 15, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

FI (1)