Back to resultsPharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
Primary Purpose
Acute Pain
Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
paracetamol Uniflash (125 mg/ 1.25 mL)
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pain
Eligibility Criteria
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.
Sites / Locations
- Raptim Research Pvt. Ltd.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
paracetamol Uniflash (125 mg/ 1.25 mL)
Arm Description
1 sachet of paracetamol Uniflash 125mg / 1.25 mL
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence and severity of adverse events (serious and non-serious adverse events)
Full Information
NCT ID
NCT05406752
First Posted
June 1, 2022
Last Updated
October 3, 2022
Sponsor
Unither Pharmaceuticals, France
Collaborators
Raptim Research
1. Study Identification
Unique Protocol Identification Number
NCT05406752
Brief Title
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2022 (Actual)
Primary Completion Date
July 23, 2022 (Actual)
Study Completion Date
July 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unither Pharmaceuticals, France
Collaborators
Raptim Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
paracetamol Uniflash (125 mg/ 1.25 mL)
Arm Type
Experimental
Arm Description
1 sachet of paracetamol Uniflash 125mg / 1.25 mL
Intervention Type
Drug
Intervention Name(s)
paracetamol Uniflash (125 mg/ 1.25 mL)
Intervention Description
Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Primary Outcome Measure Information:
Title
Paracetamol Pharmacokinetic profiles after single dose
Description
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
Time Frame
Up to 12 hours post dose
Title
Paracetamol Pharmacokinetic profiles after single dose
Description
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
Time Frame
Up to 12 hours post dose
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Description
Occurrence and severity of adverse events (serious and non-serious adverse events)
Time Frame
Up to 12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Raptim Research Pvt. Ltd.
City
Navi Mumbai
ZIP/Postal Code
400710
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
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