Effect of Duloxetine and Venlafaxine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol: A Three-phase Randomized Balanced Cross-over Study in Healthy Volunteers

NCT ID: NCT01443520

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-01-31

Brief Summary

Tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. After oral administration, tramadol is rapidly and almost completely absorbed. Tramadol is extensively metabolised by O- and N-demethylation, which are catalysed by the liver CYP-450 enzymes. O-desmethyltramadol is an active metabolite and its formation is catalysed by CYP2D6. This study is aimed to investigate the possible interaction of oral tramadol with duloxetine and venlafaxine. Duloxetine is known to inhibit CYP2D6. Twelve healthy male or female adult non-smoking volunteers aged 18-40 years with body weights within ±15% of the ideal weight for height are taken into the study. Primary endpoints of the study are plasma concentrations of tramadol and its metabolites.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

The subjects will be given orally placebo twice a day for 8 days prior to the study.

Duloxetine

Group Type: ACTIVE_COMPARATOR

Duloxetine

Intervention Type: DRUG

The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.

Venlafaxine

Group Type: ACTIVE_COMPARATOR

Venlafaxine

Intervention Type: DRUG

The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.

Interventions

Placebo

The subjects will be given orally placebo twice a day for 8 days prior to the study.

Intervention Type: DRUG

Duloxetine

The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.

Intervention Type: DRUG

Venlafaxine

The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Age 18-40
• Body weight 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
• 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
• Any history of coagulation abnormality, also in first degree relatives

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

2011-003259-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

97/180/2011

Identifier Type: -

Identifier Source: org_study_id