Clinical trial

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.

Name

UP-CLI-2021-002

Description

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

Trial arms

Trial start

2022-07-22

Estimated PCD

2022-07-23

Trial end

2022-07-23

Status

Completed

Phase

Early phase I

Treatment

paracetamol Uniflash (125 mg/ 1.25 mL)

Oromucosal solution (125 mg/ 1.25 mL) for buccal route

Arms:

paracetamol Uniflash (125 mg/ 1.25 mL)

Size

Primary endpoint

Paracetamol Pharmacokinetic profiles after single dose

Up to 12 hours post dose

Paracetamol Pharmacokinetic profiles after single dose

Up to 12 hours post dose

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2022-10-04

1 organization

1 product

1 indication

Organization

Unither Pharmaceuticals

Product

Paracetamol Uniflash

Indication

Pain