Interaction Between tropisétron / granisétron - paracétamol

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is a Crossover study, double-blind, randomized, controlled versus placebo.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: 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.