- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05406752
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
October 3, 2022 updated by: Unither Pharmaceuticals, France
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.
This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL)
for buccal use after single dose.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Navi Mumbai, India, 400710
- Raptim Research Pvt. Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: paracetamol Uniflash (125 mg/ 1.25 mL)
1 sachet of paracetamol Uniflash 125mg / 1.25 mL
|
Oromucosal solution (125 mg/ 1.25 mL) for buccal route
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Paracetamol Pharmacokinetic profiles 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 |
Up to 12 hours post dose
|
Paracetamol Pharmacokinetic profiles 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
|
Up to 12 hours post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Up to 12 hours
|
Occurrence and severity of adverse events (serious and non-serious adverse events)
|
Up to 12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 22, 2022
Primary Completion (Actual)
July 23, 2022
Study Completion (Actual)
July 23, 2022
Study Registration Dates
First Submitted
June 1, 2022
First Submitted That Met QC Criteria
June 1, 2022
First Posted (Actual)
June 6, 2022
Study Record Updates
Last Update Posted (Actual)
October 4, 2022
Last Update Submitted That Met QC Criteria
October 3, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UP-CLI-2021-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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