Acute Pain
Conditions
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.
Interventions
DRUGparacetamol Uniflash (125 mg/ 1.25 mL)
Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Sponsors
Raptim Research
Unither Pharmaceuticals, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Paracetamol Peak Plasma Concentration (Cmax) After Single Dose | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-related Adverse Events | Up to 12 hours | Occurrence and severity of adverse events (serious and non-serious adverse events) |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paracetamol Uniflash (125 mg/ 1.25 mL) 1 sachet of paracetamol Uniflash 125mg / 1.25 mL
paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Paracetamol Uniflash (125 mg/ 1.25 mL) | — |
|---|---|---|
| Age, Continuous | 29.97 years STANDARD_DEVIATION 6.31 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment India | 32 Participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 32 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 3 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
Primary
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) 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
Time frame: Up to 12 hours post dose
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Uniflash (125 mg/ 1.25 mL) | Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose | 7097.07 hr*ng/mL | Standard Deviation 1378.45 |
Primary
Paracetamol Peak Plasma Concentration (Cmax) 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
Time frame: Up to 12 hours post dose
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paracetamol Uniflash (125 mg/ 1.25 mL) | Paracetamol Peak Plasma Concentration (Cmax) After Single Dose | 2181.04 ng/mL | Standard Deviation 1148.85 |
Secondary
Number of Treatment-related Adverse Events
Occurrence and severity of adverse events (serious and non-serious adverse events)
Time frame: Up to 12 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paracetamol Uniflash (125 mg/ 1.25 mL) | Number of Treatment-related Adverse Events | 0 adverse events |