Status:
COMPLETED
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Lead Sponsor:
Unither Pharmaceuticals, France
Collaborating Sponsors:
Raptim Research
Conditions:
Acute Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05406752
Start Date
July 22 2022
End Date
July 23 2022
Last Update
December 13 2024
Active Locations (1)
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1
Raptim Research Pvt. Ltd.
Navi Mumbai, India, 400710