Paracétamol PMB by Sublingual et Buccal Routes

Healthy Volunteers Clinical Trial

Official title:

Pharmacodynamic Study of 125 mg of Paracetamol Permucosal Administered by Sublingual and Buccal Route

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206985
• Other study ID #: CHU-0081
• Secondary ID: 2010-018746-30
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2010
• Last updated: January 26, 2012
• Start date: October 2010
• Est. completion date: March 2011

Study information

• Verified date: January 2012
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Crossover study, double-blind, randomized, controlled versus placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

• Free from any treatment in the 7 days preceding inclusion including no use of analgesics or anti-inflammatories

Exclusion Criteria:

• 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

• Pathology evolutionary time of the review for inclusion.

• 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. ..).

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Unither SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain threshold testing mechanical stimulation (von Frey electronic)		T0-5min, T0+3min, T0+7min, T0+15min, T0+30min, T0+50min, T0+90min	Yes
Secondary	Evaluation of the acceptability of the permucosal product by the subject (evaluation questionnaire).		T0+70min	Yes
Secondary	Analysing a Sample of saliva for enzymatic determination (pharmacogenomics analysis)		T0-10min	Yes