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Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03562780
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
Chinese University of Hong Kong
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Fortolin Tab 500mg Drug: Panadol Caplet 500mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Bioequivalence Study on Two Paracetamol Tablet Formulations
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: Fortolin Tab 500mg
Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.
Other Name: Acetaminophen Tablet 500mg

Active Comparator: 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.
Drug: Panadol Caplet 500mg
Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.
Other Name: Acetaminophen Caplet 500mg




Primary Outcome Measures :
  1. Peak drug concentration (Cmax) of paracetamol [ Time Frame: 12 hours ]
  2. Area under the drug plasma concentration-time curve (AUC) of paracetamol [ Time Frame: 12 hours ]

Secondary Outcome Measures :
  1. Time to maximum concentration (Tmax) of paracetamol [ Time Frame: 12 hours ]
  2. Terminal elimination half-life (t1/2) of paracetamol [ Time Frame: 12 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562780


Locations
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Hong Kong
Phase 1 Clinical Trial Centre, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
Fortune Pharmacal Co., Ltd.
Chinese University of Hong Kong
Investigators
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Principal Investigator: Prof. Zhong ZUO School of Pharmacy, The Chinese University of Hong Kong
Study Director: Dr. Andrea OY Luk Phase I Clinical Trial Centre, The Chinese University of Hong Kong

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Responsible Party: Fortune Pharmacal Co., Ltd.
ClinicalTrials.gov Identifier: NCT03562780    
Other Study ID Numbers: BABE-P18-107
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics