Pilot Study of Pharmacology of Paracetamol Administered Per-oral Mucosa

NCT00982215 | Completed Phase 1

• 1 other identifier: CHU-0057
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Paracetamol is the centrally acting analgesic most commonly used in the world, indicated for the symptomatic treatment of fever and pain in mild to moderate. It comes in different formulations for oral, intravenous and rectal. The IV route allows rapid passage of paracetamol in the systemic arterial circulation and thus the brain, faster distribution evidenced a higher plasma concentration compared with oral and rectal. However the IV route also has disadvantages well known risks iatrogenic perfusion is an invasive lengthy, unpleasant and painful. The way per-Albus not to date used for the administration of paracetamol. It is a path nonetheless very interesting 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 a very rapid action. Furthermore, the terminal per-oral mucosa, less restrictive than IV administration and faster than oral administration, requires a simple medical gesture without special surveillance after administration, produces no pain or risk of infection for the patient (in contrast to the IV). It is interesting to test a new dosage form per-oral mucosa of paracetamol and compare pharmacological level (pharmacokinetics and pharmacodynamics) with the only dosage form of reference used by the IV route.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Kinetics of plasma concentrations of paracetamol

  after administration of paracetamol

Secondary Outcomes (2)

• Change in pain threshold testing mechanical stimulation (von Frey electronic). Follow-up to the pain assessed by VAS (visual analog rating)

  after administration of paracetamol

• Variation of the amplitude of brain wave N2P2 induced thermal stimulus at the forearm (Evoked Potentials thermal)

  after administration of paracetamol

Interventions

Kinetics of plasma concentrations of paracetamol DRUG

Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.

Placebo DRUG

Pilot study of Pharmacology Paracetamol administered per-oral mucosa PMB. Crossover study, double-blind, randomized, controlled versus placebo.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• 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
• Values of vital signs before administration of the test products:
• NOT 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
• Hypersensitivity to paracetamol
• History of hepatitis B or C
• Severe renal impairment
• Hepatic insufficiency
• 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 (aphthae)

Sponsors & Collaborators

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

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, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 30, 2012

Record last verified: 2012-01