Effect of duloxetine and venlafaxine on the pharmacokinetics and pharmacodynamics of oral tramadol: A three-phase randomized balanced cross-over study in healthy volunteers

• Conditions: Acute postoperative pain and chronic pain syndromes; MedDRA version: 14.0Level: LLTClassification code 10066714Term: Acute painSystem Organ Class: 10018065 - General disorders and administration site conditions; MedDRA version: 14.0Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 10018065 - General disorders and administration site conditions

• Registration Number: EUCTR2011-003259-20-FI
• Lead Sponsor: niversity of Turku

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-16
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-Twelve male or female adult non-smoking volunteers
-aged 18-40 years
-body weights within ±15% of the ideal weight for height
-no previous or chronic diseases
laboratory testing to prove that they are in good health.
-negative result in modified Finnish version of the Abuse Questions
-normal laboratory screening results
-negative urine sample for glucose, proteins and drugs with addiction potential
-Blood pressure in sitting position must be within normal limits
-Base line ECG must be normal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. A previous history of intolerance to the study drugs or to related compounds and additives.
2. Concomitant drug therapy of any kind for at least 14 days prior to the study.
3. Subjects younger than 18 years and older than 40 years.
4. Existing or recent significant disease.
5. History of hematological, endocrine, metabolic or gastrointestinal disease, including gut motility disorders.
6. History of asthma or any kind of drug allergy.
7. 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.
8. A positive test result for urine toxicology.
9. A yes” answer to any one of the Abuse Questions.
10. Pregnancy or nursing.
11. Donation of blood for 4 weeks prior and during the study.
12. Special diet or life style conditions which would compromise the conditions of the study or interpretation of
the results.
13. Participation in any other studies involving investigational or marketed drug products concomitantly or within
one month prior to the entry into this study.
14. Smoking for one month before the start of the study and during the whole study period.
15. Any history of coagulation abnormality, also in first degree relatives

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the possible pharmacokinetic interaction between the comparator and the study drug;Secondary Objective: To investigate the pharmacologic effects of the possible pharmacokinetic interaction;Primary end point(s): AUC, T½, Cmax and Tmax of tramadol and ODMT