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

NCT05406752 | Completed Phase 1 Results

• 1 other identifier: UP-CLI-2021-002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Outcome Measures

Primary Outcomes (2)

• Paracetamol Peak Plasma Concentration (Cmax) After Single 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

  Up to 12 hours post dose

• Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single 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

  Up to 12 hours post dose

Secondary Outcomes (1)

• Number of Treatment-related Adverse Events

  Up to 12 hours

Study Arms (1)

paracetamol Uniflash (125 mg/ 1.25 mL)

EXPERIMENTAL

1 sachet of paracetamol Uniflash 125mg / 1.25 mL

Drug: paracetamol Uniflash (125 mg/ 1.25 mL)

Interventions

paracetamol Uniflash (125 mg/ 1.25 mL) DRUG

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

paracetamol Uniflash (125 mg/ 1.25 mL)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unither Pharmaceuticals, France: lead
• Raptim Research: collaborator

Study Sites (1)

Raptim Research Pvt. Ltd.

Navi Mumbai, 400710, India

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Non-Clinical & Clinical Project Manager
• Organization: Unither-Pharmaceuticals

clinicaltrials@unither-pharma.com

+33 (0)1 44 63 51 78

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: July 22, 2022
• Primary Completion: July 23, 2022
• Study Completion: July 23, 2022
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)