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Completed

NCT Number: NCT05406752

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

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

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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Raptim Research Pvt. Ltd.

Navi Mumbai, 400710, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paracetamol Uniflash (125 mg/ 1.25 mL)

Drug

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

Primary outcomes

  1. Paracetamol Peak Plasma Concentration (Cmax) After Single Dose

    Time frame: 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

  2. Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose

    Time frame: 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 outcomes

  1. Number of Treatment-related Adverse Events

    Time frame: Up to 12 hours

    Occurrence and severity of adverse events (serious and non-serious adverse events)

Sponsors and collaborators

Lead sponsor

Unither Pharmaceuticals, France

Industry

Collaborators

  • Raptim Research

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 6, 2022
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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