Status:
COMPLETED
Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol
Lead Sponsor:
Turku University Hospital
Conditions:
Pharmacokinetics
Pharmacodynamics
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
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 extensi...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Age 18-40
- Body weight within ±15% of the ideal weight for height
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01214941
Start Date
September 1 2010
End Date
December 1 2010
Last Update
April 13 2011
Active Locations (1)
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1
Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University and Turku University Hospital
Turku, Finland, 20521