NCT03562780

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2019

Completed
Last Updated

July 31, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

June 8, 2018

Last Update Submit

July 29, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Peak drug concentration (Cmax) of paracetamol

    12 hours

  • Area under the drug plasma concentration-time curve (AUC) of paracetamol

    12 hours

Secondary Outcomes (2)

  • Time to maximum concentration (Tmax) of paracetamol

    12 hours

  • Terminal elimination half-life (t1/2) of paracetamol

    12 hours

Study Arms (2)

Fortolin Tab 500mg

EXPERIMENTAL

During the study session, healthy subjects will be administered a single oral dose of Fortolin Tab 500mg after an overnight fast of approximately 10 hours.

Drug: Fortolin Tab 500mg

Panadol Caplet 500mg

ACTIVE COMPARATOR

During the study session, healthy subjects will be administered a single oral dose of Panadol Caplet 500mg after an overnight fast of approximately 10 hours.

Drug: Panadol Caplet 500mg

Interventions

Fortolin Tab 500mgDRUG

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

Also known as: Acetaminophen Tablet 500mg
Fortolin Tab 500mg
Panadol Caplet 500mgDRUG

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

Also known as: Acetaminophen Caplet 500mg
Panadol Caplet 500mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and non-pregnant female, 18 to 55 years of age
  • Body Mass Index (BMI) between 18 to 25 kg/m2
  • Accessible vein for blood sampling
  • High probability for compliance and completion of the study
  • Female subjects who are surgically sterile or post-menopausal. Or female subjects of child bearing potential agree to practice abstinence or take effective contraceptive methods (e.g.implanted contraceptives, intra-uterine device or consistent condom plus spermicide use) from the start of screening until two weeks of last dose administration to prevent pregnancy.
  • Have signed the written informed consent to participate in the study.

You may not qualify if:

  • Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic and other diseases
  • Clinically significant abnormality in physical examination, vital signs, laboratory test results and ECG evaluation
  • Positive results of hepatitis B
  • Moderate smoker (more than 2 cigarettes a day within 3 months prior to the start of first dosing)
  • Moderate consumption of alcohol (more than one drink per day within 3 months prior to the start of first dosing)
  • Have lost or donated more than 350 ml of blood within 3 months prior to the start of first dosing
  • Use of paracetamol or other analgesic/antipyretic medications within 4 weeks before first dosing
  • Volunteer in any other clinical drug study within 2 months prior to the start of first dosing
  • Hypersensitivity to paracetamol or other drugs in its class
  • History of drug abuse in any form
  • Female subjects who are breastfeeding or pregnant
  • Subjects who are considered not suitable in participating the study due to other factors judged by investigators

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Prof. Zhong ZUO

    School of Pharmacy, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

  • Dr. Andrea OY Luk

    Phase I Clinical Trial Centre, The Chinese University of Hong Kong

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 19, 2018

Study Start

November 30, 2018

Primary Completion

March 1, 2019

Study Completion

April 8, 2019

Last Updated

July 31, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)