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

Acute Pain Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406752
• Other study ID #: UP-CLI-2021-002
• Status: Completed
• Phase: Phase 1
• Start date: July 22, 2022
• Est. completion date: July 23, 2022

Study information

• Verified date: October 2022
• Source: Unither Pharmaceuticals, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 23, 2022
• Est. primary completion date: July 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain

Intervention

Drug:
• paracetamol Uniflash (125 mg/ 1.25 mL)
Oromucosal solution (125 mg/ 1.25 mL) for buccal route

Locations

Country	Name	City	State
India	Raptim Research Pvt. Ltd.	Navi Mumbai

Sponsors (2)

Lead Sponsor	Collaborator
Unither Pharmaceuticals, France	Raptim Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paracetamol Pharmacokinetic profiles 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
Primary	Paracetamol Pharmacokinetic profiles 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	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Occurrence and severity of adverse events (serious and non-serious adverse events)	Up to 12 hours