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

Unither Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Acute Pain

Treatments: Drug: paracetamol Uniflash (125 mg/ 1.25 mL)

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05406752

UP-CLI-2021-002

Details and patient eligibility

About

This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.

Enrollment: 32 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

paracetamol Uniflash (125 mg/ 1.25 mL)

Experimental group

Description:

1 sachet of paracetamol Uniflash 125mg / 1.25 mL

Treatment:

Drug: paracetamol Uniflash (125 mg/ 1.25 mL)