Phase 1
N=32
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT05406752 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Paracetamol Peak Plasma Concentration (Cmax) After Single Dose — 2181.04 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- paracetamol Uniflash (125 mg/ 1.25 mL) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unither Pharmaceuticals, France
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paracetamol Peak Plasma Concentration (Cmax) After Single Dose |
2181.04 | — |
| PRIMARY Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose |
7097.07 | — |
| SECONDARY Number of Treatment-related Adverse Events |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and non-pregnant female human subjects, age 18 - 45 years.
- Body Mass Index between 18.5-30 Kg / m2 .
- Subjects with normal findings .
- Willingness to follow the protocol requirements
Exclusion Criteria
- History of allergy or hypersensitivity intolerance to paracetamol and ethanol
- Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, dermatological, immunological or psychiatric diseases, or organ dysfunction;
- Lactating or nursing female subjects;
- History of difficulty in accessibility of veins in arms.
Data sourced from ClinicalTrials.gov (NCT05406752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.