Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2019-04-08

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Fortolin Tab 500mg

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.

Group Type EXPERIMENTAL

Fortolin Tab 500mg

Intervention Type DRUG

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

Panadol Caplet 500mg

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.

Group Type ACTIVE_COMPARATOR

Panadol Caplet 500mg

Intervention Type DRUG

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

Interventions

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Fortolin Tab 500mg

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

Intervention Type DRUG

Panadol Caplet 500mg

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

Intervention Type DRUG

Other Intervention Names

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Acetaminophen Tablet 500mg Acetaminophen Caplet 500mg

Eligibility Criteria

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Inclusion Criteria

1. Male and non-pregnant female, 18 to 55 years of age
2. Body Mass Index (BMI) between 18 to 25 kg/m2
3. Accessible vein for blood sampling
4. High probability for compliance and completion of the study
5. 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.
6. Have signed the written informed consent to participate in the study.

8. Use of paracetamol or other analgesic/antipyretic medications within 4 weeks before first dosing
9. Volunteer in any other clinical drug study within 2 months prior to the start of first dosing
10. Hypersensitivity to paracetamol or other drugs in its class
11. History of drug abuse in any form
12. Female subjects who are breastfeeding or pregnant
13. Subjects who are considered not suitable in participating the study due to other factors judged by investigators

Exclusion Criteria

1. Clinically significant cardiovascular, hepatic, renal, gastrointestinal, neurological, psychiatric, metabolic and other diseases
2. Clinically significant abnormality in physical examination, vital signs, laboratory test results and ECG evaluation
3. Positive results of hepatitis B
4. Moderate smoker (more than 2 cigarettes a day within 3 months prior to the start of first dosing)
5. Moderate consumption of alcohol (more than one drink per day within 3 months prior to the start of first dosing)
6. Have lost or donated more than 350 ml of blood within 3 months prior to the start of first dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes