NCT06855576

Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions

A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg (Haleon) to Assess Bioequivalence With Alvedon 500 mg Film-Coated Tablet (Haleon, Sweden) and Panadol 500 mg Film-Coated Tablet (Haleon, Australia) in Healthy Adult Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: HALEON · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and the Australian marketed Panadol (paracetamol) 500 mg film-coated tablets as reference products.

Detailed description

This will be a single center, open-label, randomized (order of treatments), balanced, 3-period, 3-sequence, single dose, change-over trial with oral administration under fasting conditions separated by a washout period of at least 72 hours. Fifty-four healthy participants of both sexes (27 male, 27 female) are intended to be randomized to obtain 42 evaluable participants. The investigational products will be administered in fasted state as single oral doses of 500 mg paracetamol tablet. 1 tablet of test and 1 film-coated tablet of reference 1 and 1 film-coated tablet of reference 2 will be administered in a cross-over manner. Blood sampling will be performed over 24-hour post dose in order to characterize pharmacokinetic parameters.

Conditions

• Fever
• Pain

Interventions

Type	Name	Description
DRUG	Paracetamol ODT	Experimental Paracetamol 500 mg ODT
DRUG	Alvedon film-coated tablet	Marketed Paracetamol 500 mg film-coated tablet
DRUG	Panadol film-coated Tablet	Marketed Paracetamol 500 mg film-coated tablet

Timeline

• Start date: 2025-03-05
• Primary completion: 2025-04-17
• Completion: 2025-04-17
• First posted: 2025-03-04
• Last updated: 2025-05-06

Locations

1 site across 1 country: Germany