Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Healthy Clinical Trial

Official title:

Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562780
• Other study ID #: BABE-P18-107
• Status: Completed
• Phase: Phase 1
• Start date: November 30, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: June 2019
• Source: Fortune Pharmacal Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 8, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Fortolin Tab 500mg
Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.
• Panadol Caplet 500mg
Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.

Locations

Country	Name	City	State
Hong Kong	Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Fortune Pharmacal Co., Ltd.	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak drug concentration (Cmax) of paracetamol		12 hours
Primary	Area under the drug plasma concentration-time curve (AUC) of paracetamol		12 hours
Secondary	Time to maximum concentration (Tmax) of paracetamol		12 hours
Secondary	Terminal elimination half-life (t1/2) of paracetamol		12 hours