At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 32 enrolled
Drug / intervention
paracetamol Uniflash (125 mg/ 1.25 mL)drug
Likely dose
Paracetamol Uniflash 125 mg/1.25 mL oromucosal solution, single buccal doseAI-extracted
Key inclusion· 3
- ✓Age 18-45 years
- ✓BMI 18.5-30 kg/m²
- ✓Normal clinical findings
Key exclusion· 4
- ✕Allergy or hypersensitivity to paracetamol or ethanol
- ✕Significant history or current evidence of malignancy or chronic infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, dermatological, immunological or psychiatric disease, or organ dysfunction
- ✕Pregnancy or lactation
- ✕History of difficulty with vein accessibility in arms
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 1 clinical trial evaluating paracetamol Uniflash (125 mg/ 1.25 mL) for Acute Pain. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pain
CountriesIndia
CollaboratorsRaptim Research
Timeline
Phase 1CompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartJul 2022
Primary CompletionJul 2022
TodayJul 2026
First PostedJun 6, 2022
Enrollment StartJul 22, 2022
Primary CompletionJul 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1 daysPosted 4.1 years ago
Interventions
paracetamol Uniflash (125 mg/ 1.25 mL)drug
Oromucosal solution (125 mg/ 1.25 mL) for buccal route