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

Turku University Hospital (TYKS)

Status and phase

Completed

Phase 4

Conditions

Healthy

Treatments

Drug: Duloxetine

Drug: Venlafaxine

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01443520

97/180/2011

2011-003259-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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