Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06855576
PHASE1

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

Sponsor: HALEON

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2025-03-05

Completion Date

2025-04-17

Last Updated

2026-07-01

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

SocraTec R&D GmbH

Erfurt, Thuringia, Germany