Acute PainPhase 1NCT05406752

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

A Phase 1 study testing paracetamol Uniflash (125 mg/ 1.25 mL) in people with Acute Pain, run by Unither Pharmaceuticals, France at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Acute Pain
What is being tested?: paracetamol Uniflash (125 mg/ 1.25 mL)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteIndia
Study dates: 22 Jul 2022to 23 Jul 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

India1 site

Raptim Research Pvt. Ltd.
Navi Mumbai, 400710

Other trials in India

About this study

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.

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

Conditions: Acute Pain
Being tested: paracetamol Uniflash (125 mg/ 1.25 mL)
Medical subject headings: Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05406752
Study group	Role	What they receive
paracetamol Uniflash (125 mg/ 1.25 mL)	Experimental	1 sachet of paracetamol Uniflash 125mg / 1.25 mL Receives: Drug: paracetamol Uniflash (125 mg/ 1.25 mL)

What is being measured

The primary outcome is the main question the study is designed to answer.

Paracetamol Peak Plasma Concentration (Cmax) 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
Measured: Up to 12 hours post dose
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) 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
Measured: Up to 12 hours post dose

Secondary outcomes (1)

Number of Treatment-related Adverse Events
Occurrence and severity of adverse events (serious and non-serious adverse events)
Measured: Up to 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jul 202223 Jul 2022

First posted6 Jun 2022
Study start22 Jul 2022
Primary completion23 Jul 2022
Study completion23 Jul 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05406752
Sponsor's protocol ID: UP-CLI-2021-002
Status last verified: Oct 2024
First submitted: 1 Jun 2022
Last updated: 13 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT05406752
Acronym / sponsor ID: UP-CLI-2021-002
Conditions: Acute Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Unither Pharmaceuticals, FranceIndustry (pharma, biotech, devices)
Collaborators: Raptim Research
Study start: 22 Jul 2022 (actual)
Primary completion: 23 Jul 2022 (actual)
Study completion: 23 Jul 2022 (actual)
First posted: 6 Jun 2022 (actual)
Results: Posted 13 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
paracetamol Uniflash (125 mg/ 1.25 mL)	Experimental	Drug: paracetamol Uniflash (125 mg/ 1.25 mL)1 sachet of paracetamol Uniflash 125mg / 1.25 mL

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
paracetamol Uniflash (125 mg/ 1.25 mL)Oromucosal solution (125 mg/ 1.25 mL) for buccal route	Drug	paracetamol Uniflash (125 mg/ 1.25 mL)

Primary outcome

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
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

1 secondary outcome

Number of Treatment-related Adverse Events
Time frame: Up to 12 hours

Results and safety

Results posted to the registry on 13 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paracetamol Uniflash (125 mg/ 1.25 mL)	32	32

Primary outcome: Paracetamol Peak Plasma Concentration (Cmax) After Single Dose

Time frame: Up to 12 hours post dose. Mean (Standard Deviation). Unit: ng/mL

Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n = 32
Value	2181.04 (1148.85)

Population analysed: Full Analysis Set

Primary outcome: Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose

Time frame: Up to 12 hours post dose. Mean (Standard Deviation). Unit: hr*ng/mL

Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n = 32
Value	7097.07 (1378.45)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paracetamol Uniflash (125 mg/ 1.25 mL)	0 of 32 (0%)	3 of 32 (9.4%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing paracetamol Uniflash (125 mg/ 1.25 mL) in people with Acute Pain, run by Unither Pharmaceuticals, France at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Paracetamol Peak Plasma Concentration (Cmax) After Single Dose (time frame: Up to 12 hours post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05406752.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.