Interaction Between tropisétron / granisétron - paracétamol

NCT01226381 | Completed Phase 1

• 2 other identifiers: CHU-00832010-020509-34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Paracetamol and setrons; No disease, healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Change in pain threshold testing mechanical stimulation (von Frey electronic)

  Time 0 + 1h, time0 +3h, time 0 +3h30, timet0+12h30, time 0+14h, time0+14h30, time0+23h30, time0+25h, timt0+25h30, time0+34h30, time0+36h, time0+36h30

Secondary Outcomes (1)

• Assays setrons, paracetamol and its metabolites

  Time 0 + 1h, time0 +3h, time 0 +3h30, timet0+12h30, time 0+14h, time0+14h30, time0+23h30, time0+25h, timt0+25h30, time0+34h30, time0+36h, time0+36h30

Interventions

Von Frey electronic DRUG

This protocol is based on a study of the interaction setron / paracetamol at 4 different levels of plasma concentrations, by repeating the tests at set intervals, while concentrations of setrons down gradually (half-life of 8 to 10 am ) after a single administration. In addition, the interindividual variability of the effects of paracetamol will be studied, and linking with certain genetic polymorphisms reported by the subjects tested

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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%).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

• Claude DUBRAY

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 22, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: May 1, 2011
• Last Updated: February 3, 2012

Record last verified: 2012-02

Locations

FR (1)