Clinical Bioequivalence Study on Two Paracetamol Tablet F... | NCT03562780

Studies
Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

NCT03562780

Sponsor

Fortune Pharmacal Co., Ltd.

Status

Completed

Last Update Posted

Jul 31, 2019Actual

Enrollment

20Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Fortolin Tab 500mg
Panadol Caplet 500mg

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Apr 8, 2019Actual

First Submitted Date

Jun 8, 2018

First Submission Date that Met QC Criteria

Jun 8, 2018

First Posted Date

Jun 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2019

Last Update Posted Date

Jul 31, 2019Actual

Name	Class
Chinese University of Hong Kong	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Fortolin Tab 500mg	Drug	Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.	Fortolin Tab 500mg

Measure	Description	Time Frame
Peak drug concentration (Cmax) of paracetamol		12 hours
Area under the drug plasma concentration-time curve (AUC) of paracetamol		12 hours

Measure	Description	Time Frame
Time to maximum concentration (Tmax) of paracetamol		12 hours
Terminal elimination half-life (t1/2) of paracetamol		12 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
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

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814