Acute postoperative pain and chronic pain syndromes MedDRA version: 14.0 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.0 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Tramal
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: TRAMADOL
CAS Number: 27203-92-5
Trade Name: Cymbalta
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DULOXETINE
CAS
Sponsors
University of Turku
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland
Outcome results
None listed