HealthyPhase 1NCT03562780

Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

A Phase 1 study testing Fortolin Tab 500mg and Panadol Caplet 500mg in people with Healthy, run by Fortune Pharmacal Co., Ltd. at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Fortolin Tab 500mg and Panadol Caplet 500mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteHong Kong
Study dates: 30 Nov 2018to 8 Apr 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Show all 13Show fewer

Subjects who are taking prescription or non-prescription medications (except for contraceptives, refer to "Inclusion Criteria" section) which is likely to be required during the course of the study
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

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

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

Other trials in Hong Kong

About this study

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
Being tested: Fortolin Tab 500mg, Panadol Caplet 500mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fortolin Tab 500mgDrug
Also called Acetaminophen Tablet 500mg
Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.
Panadol Caplet 500mgDrug
Also called Acetaminophen Caplet 500mg
Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.

Study groups in NCT03562780
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Panadol Caplet 500mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Peak drug concentration (Cmax) of paracetamol
Measured: 12 hours
Area under the drug plasma concentration-time curve (AUC) of paracetamol
Measured: 12 hours

Secondary outcomes (2)

Time to maximum concentration (Tmax) of paracetamol
Measured: 12 hours
Terminal elimination half-life (t1/2) of paracetamol
Measured: 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 20188 Apr 2019

First posted19 Jun 2018
Study start30 Nov 2018
Primary completion1 Mar 2019
Study completion8 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03562780
Sponsor's protocol ID: BABE-P18-107
Status last verified: Jun 2019
First submitted: 8 Jun 2018
Last updated: 31 Jul 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
ClinicalTrials.gov ID: NCT03562780
Acronym / sponsor ID: BABE-P18-107
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Fortune Pharmacal Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: Chinese University of Hong Kong
Study start: 30 Nov 2018 (actual)
Primary completion: 1 Mar 2019 (actual)
Study completion: 8 Apr 2019 (actual)
First posted: 19 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fortolin Tab 500mg	Experimental	Drug: Fortolin Tab 500mgDuring the study session, healthy subjects will be administered a single oral dose of Fortolin Tab 500mg after an overnight fast of approximately 10 hours.
Panadol Caplet 500mg	Active comparator	Drug: Panadol Caplet 500mgDuring the study session, healthy subjects will be administered a single oral dose of Panadol Caplet 500mg after an overnight fast of approximately 10 hours.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (13 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fortolin Tab 500mgAlso: Acetaminophen Tablet 500mgFortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.	Drug	Fortolin Tab 500mg
Panadol Caplet 500mgAlso: Acetaminophen Caplet 500mgPanadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.	Drug	Panadol Caplet 500mg

Primary outcome

Peak drug concentration (Cmax) of paracetamol
Time frame: 12 hours
Area under the drug plasma concentration-time curve (AUC) of paracetamol
Time frame: 12 hours

2 secondary outcomes

Time to maximum concentration (Tmax) of paracetamol
Time frame: 12 hours
Terminal elimination half-life (t1/2) of paracetamol
Time frame: 12 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prof. Zhong ZUO principal investigator

School of Pharmacy, The Chinese University of Hong Kong

Dr. Andrea OY Luk study director

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fortolin Tab 500mg and Panadol Caplet 500mg in people with Healthy, run by Fortune Pharmacal Co., Ltd. at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak drug concentration (Cmax) of paracetamol (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03562780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.