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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05406752
Other study ID # UP-CLI-2021-002
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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