Pharmacokinetics of a Standard Paracetamol Tablet and Oral Solution After Oral Administration in Chinese Healthy Volunteers

March 24, 2014 updated by: Feifan Xie, Central South University
Drug dissolution in vivo play a crucial role for the bioavailability and therapeutic of an orally administered solid dosage form. The aim of this study was to evaluate the pharmacokinetics of a standard paracetamol tablet in comparison with oral solution in Chinese healthy volunteers. Based on the Noyes-Whitney equation and pharmacokinetics parameters, investigators trend to propose a method to estimate in vivo dissolution time and dissolution kinetics of solid dosage form.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Sex: Male or female (limited to PK study)
  2. Healthy volunteers, age: 18-45（medical history, physical examination, vital signs, ECG and lab tests are qualified during screening）
  3. Body Mass Index（BMI）:19~24 or body weight is not less than 50Kg
  4. Non-pregnant women confirmed by pregnancy test
  5. Vital Signs: after 3 minutes supination, the following measurements criteria should be within ranges: body temperature (axillary temperature), 36.0~37.0 ℃; blood pressure, SBP 90~140mmHg（12.0~18.7kpa）and DBP 60~90mmHg（8.0~12.0kpa）; arterial pulse: 60~100 bpm
  6. Non-hypersensitivity to this product or its similar product
  7. Non-smoker, non-alcoholic
  8. Subject must be able to sign Inform Consent prior to participation into this study
  9. Subject must be able to communicate with investigator and comply with study protocol.

Exclusion Criteria:

Subjects meet with one or several of the following criteria should be excluded:

  1. Subjects failed in physical examination
  2. Pregnant or nursing women
  3. Administration of a known drug that can cause damage to organs within 3 months
  4. Administration of any prescription drug or non-prescription drug 2 weeks before initial dose
  5. Before initial dose, participation in any other clinical trials within 3 months
  6. Blood donation 3 months before this study, or plan to have blood donation during or one month after this study
  7. Diagnosis of clinical evident diseases 2 weeks before initial dose
  8. Primary diseases to vital organs
  9. Physically or mentally disabled
  10. Medical history of specific allergy (asthma, measles, eczematous dermatitis), or known to allergic to similar (including excipients)

  11. Any other surgical or internal medicinal conditions that might cause damage to study subjects or will change the absorption, distribution, metabolism and elimination of investigational drug, including:

    • inflammatory intestinal syndrome, peptic ulcer, alimentary tract hemorrhage
    • a history of severe gastrointestinal tract operation, such as gastrectomy, gastrosmoty / jejunostomy or large bowel resection
    • a history of hepatic disease or laboratory examination findings such as ALT, AST, γ-GT or T-Bili showing clinically significant abnormalities to liver
    • a history of renal disease or laboratory examination findings such as creatinine, urea nitrogen, or albuminuria showing clinically significant abnormalities to kidney
    • urination disorder or dysuresia.
  12. A history of immunological deficiency disease, or HIV positive
  13. HBV or HCV positive
  14. Women undergone menstrual period during study
  15. Consumption of a significant amount of smoking or drinking, that is drinking more than 28 units of alcohol per week (1 unit: 285ml of beer, 25ml of liquor, or 1 glass of wine), or smoking more than 2 cigarettes
  16. Frequent use of sedatives, hypnotics, stabilizers or other addictive drugs
  17. Consumption of more than 8 cups of tea, coffee, and or caffeine beverages
  18. Unable to complete this study for any others reasons.
  19. Investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: paracetamol oral solution
dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
Drug: paracetamol oral solution
dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
Experimental: paracetamol tablet
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
Drug: paracetamol tablet
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: one month
AUC:the area under the concentration-time curve
one month
Cmax
Time Frame: one month
Cmax: maximum plasma concentration
one month
Tmax
Time Frame: one month
Tmax: the time point of maximum plasma concentration
one month
MRT
Time Frame: one month
MRT: mean residence time
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSU-YXY-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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