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Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)

NCT05406752 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2024-12-13

Study results available
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Summary

This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.

Conditions

  • Acute Pain

Interventions

DRUG

paracetamol Uniflash (125 mg/ 1.25 mL)

Oromucosal solution (125 mg/ 1.25 mL) for buccal route

Sponsors & Collaborators

  • Raptim Research

    collaborator OTHER

  • Unither Pharmaceuticals, France

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2022-07-23
Completion
2022-07-23

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05406752 on ClinicalTrials.gov