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

NCT ID: NCT05406752

Last Updated: 2024-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-22

Study Completion Date

2022-07-23

Brief Summary

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

Detailed Description

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Conditions

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Acute Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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paracetamol Uniflash (125 mg/ 1.25 mL)

1 sachet of paracetamol Uniflash 125mg / 1.25 mL

Group Type EXPERIMENTAL

paracetamol Uniflash (125 mg/ 1.25 mL)

Intervention Type DRUG

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

Interventions

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paracetamol Uniflash (125 mg/ 1.25 mL)

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Raptim Research

OTHER

Sponsor Role collaborator

Unither Pharmaceuticals, France

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Raptim Research Pvt. Ltd.

Navi Mumbai, , India

Site Status

Countries

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India

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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UP-CLI-2021-002

Identifier Type: -

Identifier Source: org_study_id