Overview

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.