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

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • 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

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
Intervention / Treatment
Experimental: paracetamol oral solution
dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
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
dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose

What is the study measuring?

Primary Outcome Measures

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.

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

May 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 19, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Estimate)

March 26, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

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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