Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Panadol Caplet 500mg; Drug: Fortolin Tab 500mg

• Registration Number: NCT03562780
• Lead Sponsor: Fortune Pharmacal Co., Ltd.

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 available

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-19
• Study Start: 2018-11-30
• Primary Completion: 2019-03-01
• Study Completion: 2019-04-08
• Status Verified: 2019-06
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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
7. 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
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Panadol Caplet 500mg	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.
Fortolin Tab 500mg	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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