Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)

• Status: Not yet recruiting
• Trial end date: 2022-07-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Unither Pharmaceuticals, France
• Collaborator: Raptim Research
• Treatments: Acetaminophen

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.