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

Phase 1

Completed

• Conditions: Acute Pain
• Interventions: Drug: paracetamol Uniflash (125 mg/ 1.25 mL)

• Registration Number: NCT05406752
• Lead Sponsor: Unither Pharmaceuticals, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-01
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-06
• Study Start: 2022-07-22
• Primary Completion: 2022-07-23
• Study Completion: 2022-07-23
• Results First Submitted: 2023-11-27
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
paracetamol Uniflash (125 mg/ 1.25 mL)	paracetamol Uniflash (125 mg/ 1.25 mL)	1 sachet of paracetamol Uniflash 125mg / 1.25 mL

Primary Outcome Measures

Name	Time	Method
Paracetamol Peak Plasma Concentration (Cmax) After Single Dose	Up to 12 hours post 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
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose	Up to 12 hours post 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

Secondary Outcome Measures

Name	Time	Method
Number of Treatment-related Adverse Events	Up to 12 hours	Occurrence and severity of adverse events (serious and non-serious adverse events)

Trial Locations

Locations (1)

Raptim Research Pvt. Ltd.; 🇮🇳 Navi Mumbai, India