Overview
Interaction Between tropisétron / granisétron - paracétamol
Status:
Completed
Completed
Trial end date:
2011-05-01
2011-05-01
Target enrollment:
0
0
Participant gender:
Male
Male
Summary
This is a Crossover study, double-blind, randomized, controlled versus placebo.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
University Hospital, Clermont-FerrandTreatments:
Acetaminophen
Granisetron
Tropisetron
Criteria
Inclusion Criteria:- 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 Criteria:
- 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.