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

NCT06855576 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-05-06

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • HALEON

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2025-04-17
Completion
2025-04-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855576 on ClinicalTrials.gov