Acute Pain Clinical Trial
Official title:
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.
Verified date | October 2022 |
Source | Unither Pharmaceuticals, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.
Status | Completed |
Enrollment | 32 |
Est. completion date | July 23, 2022 |
Est. primary completion date | July 23, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Raptim Research Pvt. Ltd. | Navi Mumbai |
Lead Sponsor | Collaborator |
---|---|
Unither Pharmaceuticals, France | Raptim Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 |
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