Phase 1 Completed N=32 Treatment

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

Postoperative Pain

Source: ClinicalTrials.gov NCT05406752 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcomePrimary: Paracetamol Peak Plasma Concentration (Cmax) After Single Dose — 2181.04 ng/mL

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.

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	—	—

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.

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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. Informational only — not medical advice.