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| Name | Class |
|---|---|
| Raptim Research | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paracetamol Uniflash (125 mg/ 1.25 mL) | Experimental | 1 sachet of paracetamol Uniflash 125mg / 1.25 mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paracetamol Uniflash (125 mg/ 1.25 mL) | Drug | Oromucosal solution (125 mg/ 1.25 mL) for buccal route |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 hours post dose |
| 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 | Up to 12 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-related Adverse Events | Occurrence and severity of adverse events (serious and non-serious adverse events) | Up to 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Raptim Research Pvt. Ltd. | Navi Mumbai | 400710 | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Full Analysis Set | Posted | Mean | Standard Deviation | ng/mL | Up to 12 hours post dose |
|
|
2 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Hepatobiliary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Non-Clinical & Clinical Project Manager | Unither-Pharmaceuticals | +33 (0)1 44 63 51 78 | clinicaltrials@unither-pharma.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2022 | Oct 29, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants |
|
|
| 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 | Posted | Mean | Standard Deviation | hr*ng/mL | Up to 12 hours post dose |
|
|
|
| Secondary | Number of Treatment-related Adverse Events | Occurrence and severity of adverse events (serious and non-serious adverse events) | Posted | Number | adverse events | Up to 12 hours |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| 3 |
| 32 |
The PI shall not make any publication or communication, written or oral, in connection with the Study and the results of the Study, whether partial or final, without the prior written consent of the sponsor (UNITHER PHARMACEUTICALS) during, and following termination or expiration of this Clinical Study Services Agreement.