Status:
COMPLETED
Interaction Between tropisétron / granisétron - paracétamol
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-40 years
Phase:
PHASE1
Brief Summary
This is a Crossover study, double-blind, randomized, controlled versus placebo.
Detailed Description
Although the mechanism of action of paracetamol is far from being elucidated, data from the literature suggest that its action would be rather central, without excluding an associated peripheral actio...
Eligibility Criteria
Inclusion
- Healthy volunteers
- Aged 18 years and more than 40 years
- Male
- Weight and size within 80 to 120% of theoretical values determined from the Lorentz formula
- Values of vital signs before administering the test products:
- Oral temperature between 35 to 37.5 ° C
- PAS between 100-140 mm Hg
- PAD between 50-90 mm Hg
- Radial pulse between 45-90 beats per minute
- Free from any chronic treatment
- Free of any active disease
- Failure to take any medication within 7 days before enrollment in the study (including no use of analgesics or anti-inflammatory)
- Cooperation and understanding to comply strictly with the requirements of the protocol
- Acceptance to give written consent
- Membership of the scheme of the French Social Security
- Acceptance of registration or the national registry of volunteers participating in research
Exclusion
- Contraindications to the administration of paracetamol:
- Known hypersensitivity to paracetamol
- History of hepatitis B or C
- Severe renal insufficiency
- Liver failure
- Contraindications to the administration of tropisetron or granisetron:
- Known hypersensitivity to tropisetron, granisetron, and / or other antagonists of 5-HT3
- Hypertension
- Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test.
- Pathology evolving at the time of assessment for inclusion.
- Excessive consumption of alcohol, tobacco (10 + cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug addiction.
- Presence of any concurrent treatment (including prescription medicines, vitamins) or taking any medication within 2 weeks before the first administration of the test.
- Topic lacking concentration during workouts nociceptive tests, or presenting training sessions after these tests a low reproducibility of the measured parameters (variability\> 20%).
- Topic participating in another clinical trial, or within the period of exclusion or who have received a total compensation of more than 4500 euros for the 12 months preceding the start of the test.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01226381
Start Date
July 1 2010
End Date
May 1 2011
Last Update
February 3 2012
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003