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Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

NCT03562780 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-07-31

No results posted yet for this study

Summary

The objective of the study is to compare the bioavailability of a generic product of paracetamol (immediate-release) with that of a reference product when administered to healthy volunteers under fasting condition. The test product is Fortolin Tab 500mg manufactured by Fortune Pharmacal Co. Ltd., and the reference product is Panadol Caplet 500mg manufactured by GlaxoSmithKline (Dungarvan) Ltd. The plasma pharmacokinetic data of paracetamol obtained from two formulations will be used to evaluate the interchangeability of the products.

Conditions

  • Healthy

Interventions

DRUG

Fortolin Tab 500mg

Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.

DRUG

Panadol Caplet 500mg

Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    collaborator OTHER

  • Fortune Pharmacal Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Prof. Zhong ZUO · School of Pharmacy, The Chinese University of Hong Kong

  • Dr. Andrea OY Luk · Phase I Clinical Trial Centre, The Chinese University of Hong Kong

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
2018-11-30
Primary Completion
2019-03-01
Completion
2019-04-08

Countries

  • Hong Kong

Study Locations

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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 NCT03562780 on ClinicalTrials.gov