Trial Outcomes & Findings for Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML) (NCT NCT05406752)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

Up to 12 hours post dose

Results posted on

2024-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Overall Study STARTED	32
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n=32 Participants 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Age, Continuous	29.97 years STANDARD_DEVIATION 6.31 • n=32 Participants
Sex: Female, Male Female	0 Participants n=32 Participants
Sex: Female, Male Male	32 Participants n=32 Participants
Region of Enrollment India	32 Participants n=32 Participants

PRIMARY outcome

Timeframe: Up to 12 hours post dose

Population: Full Analysis Set

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

Outcome measures

Outcome measures
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n=32 Participants 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Paracetamol Peak Plasma Concentration (Cmax) After Single Dose	2181.04 ng/mL Standard Deviation 1148.85

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n=32 Participants 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Paracetamol Area Under the Plasma Concentration Versus Time Curve (AUC) After Single Dose	7097.07 hr*ng/mL Standard Deviation 1378.45

SECONDARY outcome

Timeframe: Up to 12 hours

Occurrence and severity of adverse events (serious and non-serious adverse events)

Outcome measures

Outcome measures
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n=32 Participants 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Number of Treatment-related Adverse Events	0 adverse events

Adverse Events

Paracetamol Uniflash (125 mg/ 1.25 mL)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Paracetamol Uniflash (125 mg/ 1.25 mL) n=32 participants at risk 1 sachet of paracetamol Uniflash 125mg / 1.25 mL paracetamol Uniflash (125 mg/ 1.25 mL): Oromucosal solution (125 mg/ 1.25 mL) for buccal route
Hepatobiliary disorders Alanine aminotransferase increased	9.4% 3/32 • Number of events 3 • 2 days

Additional Information

Non-Clinical & Clinical Project Manager

Unither-Pharmaceuticals

Phone: +33 (0)1 44 63 51 78

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI shall not make any publication or communication, written or oral, in connection with the Study and the results of the Study, whether partial or final, without the prior written consent of the sponsor (UNITHER PHARMACEUTICALS) during, and following termination or expiration of this Clinical Study Services Agreement.
Publication restrictions are in place

Restriction type: OTHER