Clinical trial NCT03562780: Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
Official title: Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Fortune Pharmacal Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese University of Hong Kong
First posted: 2018-06-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak drug concentration (Cmax) of paracetamol
timeFrame: 12 hours
measure: Area under the drug plasma concentration-time curve (AUC) of paracetamol
timeFrame: 12 hours
Secondary outcomes:
measure: Time to maximum concentration (Tmax) of paracetamol
timeFrame: 12 hours
measure: Terminal elimination half-life (t1/2) of paracetamol
timeFrame: 12 hours
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Study officials:
affiliation: School of Pharmacy, The Chinese University of Hong Kong
name: Prof. Zhong ZUO
role: PRINCIPAL_INVESTIGATOR
affiliation: Phase I Clinical Trial Centre, The Chinese University of Hong Kong
name: Dr. Andrea OY Luk
role: STUDY_DIRECTOR
References: