Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Conditions
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Healthy

Intervention / Treatment
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* Drug: Fortolin Tab 500mg
* Drug: Panadol Caplet 500mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortolin Tab 500mg<br>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<br>* Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.<br>* Other names: Acetaminophen Tablet 500mg;|
| Active Comparator: Panadol Caplet 500mg<br>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<br>* Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.<br>* Other names: Acetaminophen Caplet 500mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

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