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

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

Official Title
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An Open-label, Single Treatment, Single Period, Single Buccal Dose Pharmacokinetic Study of Paracetamol Uniflash (125 mg/ 1.25 mL) in Healthy, Adult, Human Subjects Under Fasting Conditions.

Conditions
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Acute Pain

Intervention / Treatment
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* Drug: paracetamol Uniflash (125 mg/ 1.25 mL)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paracetamol Uniflash (125 mg/ 1.25 mL)<br>1 sachet of paracetamol Uniflash 125mg / 1.25 mL | Drug: paracetamol Uniflash (125 mg/ 1.25 mL)<br>* Oromucosal solution (125 mg/ 1.25 mL) for buccal route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paracetamol Pharmacokinetic profiles after single dose | Peak Plasma Concentration (Cmax) of paracetamol after single dose at different timepoints : Within 60 min before drug administration), at 1 min, 5 min, 10 min, 15 min, 20 min, 40 min, 1h, 2h, 4h, 6h, 8h, 10h and 12h post-dose | Up to 12 hours post dose | 
| Paracetamol Pharmacokinetic profiles after single dose | Area under the plasma concentration versus time curve (AUC) of paracetamol after single dose at different timepoints :Within 60 min before drug administration), at 1 min, 5 min, 10 min, 15 min, 20 min, 40 min, 1h, 2h, 4h, 6h, 8h, 10h and 12h post-dose | Up to 12 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Occurrence and severity of adverse events (serious and non-serious adverse events) | Up to 12 hours |