Paracétamol PMB by Sublingual et Buccal Routes

NCT01206985 | Completed Phase 1

• 2 other identifiers: CHU-00812010-018746-30
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Paracetamol is the analgesic most used, indicated in the symptomatic treatment of fever and pain of mild to moderate. It comes in different dosage forms intended for oral, intravenous and rectal. The per-oral mucosal route is not used for the administration of paracetamol. It is a very interesting way for the rapid absorption of drugs such as nitrates used in angina pectoris, as it seeks a highly vascular area (the floor of the tongue or gingival groove) and allows very rapid action. In addition, the oral administration-oral mucosa, less restrictive than IV administration and faster than oral administration, seek a single medical procedure unattended after dosing, will entail no pain or risk for infections the patient (in contrast to the IV). The investigators tested a new oral dosage form permucosal (at 250mg/ml) of paracetamol and compared at pharmacological (pharmacokinetic and pharmacodynamic) with the only dosage form of reference used by the IV route in the protocol "Pilot study Pharmacology paracetamol administered oral permucosal PMB. It seems interesting now to reduce the dose by half permucosal to assess how changing the pharmacodynamics of the form permucosal to 125mg/ml. This form will be administered in oral permucosal buccal as well as sublingual (under the pillar of the language) and compared with paracetamol in IV.

Conditions

Healthy Volunteers

Keywords

Paracetamol; per-oral mucosa PMB; No disease, healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  T0-5min, T0+3min, T0+7min, T0+15min, T0+30min, T0+50min, T0+90min

Secondary Outcomes (2)

• Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire).

  T0+70min

• Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis)

  T0-10min

Interventions

Von Frey electronic OTHER

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers.
• Aged over 18 years and not more than 50 years.
• Males or female
• Values of vital signs before administration of the test products:
• PAS between 100-140 mm Hg
• PAD between 50-90 mm Hg
• Radial pulse between 45-90 beats per minute

You may not qualify if:

• Contraindications to the administration of paracetamol
• Medical history and / or surgical judged by the investigator or his representative as being incompatible with the test, especially subjects with neuropathic pain
• Binge drinking, smoking (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day) or drug abuse.
• Subject does not meet the selection criteria regarding their ability to discriminate the sensations resulting from noxious stimuli during psychometric testing.
• Topic having all breaches of the oral mucosa (aphtes. ..).

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Unither SA: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

• Gisèle PICKERING

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 6, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: January 30, 2012

Record last verified: 2012-01

Locations

FR (1)