Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Other
Enrollment
54actual
Sites
1
Country
Germany
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-03-05 | actual | When the study began enrolling |
| Primary completion | 2025-04-17 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-17 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-04 | actual | When this record first appeared on the registry |
| Results posted | 2026-07-01 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Fever
- Pain
Interventions
- Drug: Paracetamol ODT
- Drug: Alvedon film-coated tablet
- Drug: Panadol film-coated Tablet
Primary outcomes
what the primary-completion date above is the date OFMaximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC0-tlast for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Tmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
measured Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-05-07 · 994 KB · Prot_000.pdf
Statistical Analysis Planposted 2025-03-28 · 4.2 MB · SAP_001.pdf
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