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.
Overview
- Phase
- Phase 1
- Intervention
- paracetamol Uniflash (125 mg/ 1.25 mL)
- Conditions
- Acute Pain
- Sponsor
- Unither Pharmaceuticals, France
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Paracetamol Peak Plasma Concentration (Cmax) After Single Dose
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
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.
Arms & Interventions
paracetamol Uniflash (125 mg/ 1.25 mL)
1 sachet of paracetamol Uniflash 125mg / 1.25 mL
Intervention: paracetamol Uniflash (125 mg/ 1.25 mL)
Outcomes
Primary Outcomes
Paracetamol Peak Plasma Concentration (Cmax) After Single Dose
Time Frame: Up to 12 hours post 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
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose
Time Frame: Up to 12 hours post 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
Secondary Outcomes
- Number of Treatment-related Adverse Events(Up to 12 hours)