Estimation of Paracetamol in Urine to Assess the Diurnal Variation

July 12, 2018 updated by: Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Paracetamol is an antipyretic drug that is taken orally at different times of the day in same dose. It is excreted mainly through renal route which may show diurnal variation. In this study, urinary excretion of paracetamol of 41 healthy men of same age group will be measured by HPLC after oral administration of 500 mg paracetamol tablet at morning, midday and night. The measured values will be compared in order to adjust doses of oral paracetamol at different times of the day.

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.

Detailed Description

Drug absorption, distribution, biotransformation and excretion are influenced by many different physiological functions of the body which may vary with time of the day. The time dependent changes in pharmacokinetics are due to circadian variation of human physiology and it is sometimes responsible for drug effects or adverse effects. Paracetamol is a widely used antipyretic and analgesic drug. It is usually well tolerated when used at the recommended dose. Paracetamol is a weak acidic drug that is rapidly absorbed and distributed after oral administration. It is metabolized extensively in liver and excrteted mainly through kidney as metabolites of paracetamol and some are as unchanged form. Paracetamol and its metabolites can be determined in biological fluids (urine, plasma, serum) by various mechanisms. High Performance Liquid Chromatography (HPLC) is a modern analytical chemistry technique by which paracetamol can be identified, separated and estimated from urine sample. This study is designed to investigate whether the excretion of paracetamol is changed or not if administered at same dose as oral tablet at three different times of the day. For this purpose after taking written informed consent 41 healthy men of aged 19- 23 will be provided 500 mg oral paracetamol tablet at morning, midday and night in two weeks interval and estimation of urinary paracetamol will be done by HPLC after paracetamol ingestion. A pilot study has been done and result shows highest concentration of paracetamol in urine after its oral administration found at 4th hour. Urine sample will be collected before and 4 hour after paracetamol administration in chloroform containing urine container and will be preserved in - 20 ̊C until analysis. Paracetamol standard has been collected from the same pharmaceutical company of which the drug will be used for study. Mobile phase will be consist of acetonitrile and distilled water and flow rate will be 0.5 ml/min at 25 ̊C temperature and 900 Psi pressure. The standard and sample will be analysed at a wavelength 254 nm. Total urinary paracetamol of that time will be estimated by multiplying total urinary volume in ml and concentration of paracetamol in one ml of urine. After measuring paracetamol at different times of the day, statistical analysis will be done to compare those values. If significant variation is found, adjustment of dose of oral paracetamol in different time of the day will be tried.

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.
46

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.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Comilla, Bangladesh, 3500
        • Eastern Medical College

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 23 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • The healthy male student volunteers of Eastern Medical College having age range between 19 and 23 years

Exclusion Criteria:

  • Age <19 years , >23 years
  • Volunteers on analgesic or antipyretic medication
  • Volunteers with history of hypersensitivity to paracetamol
  • Volunteers taking any enzyme inducing or enzyme inhibiting drug
  • Volunteers with impaired renal or hepatic function

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel 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.
Other: Paracetamol 500 mg tablet at Morning
Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at morning
Drug: Paracetamol 500 mg tablet at morning
Single dose oral paracetamol will be administered at 8.00 am
Other Names:
  • Tablet. Ace
Other: Paracetamol 500 mg tablet at Midday
Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at midday
Drug: Paracetamol 500 mg tablet at midday
Single dose oral paracetamol will be administered at 2.00 pm
Other Names:
  • Tablet. Ace
Other: Paracetamol 500 mg tablet at Night
Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at night
Drug: Paracetamol 500 mg tablet at night
Single dose oral paracetamol will be administered at 8.00 pm
Other Names:
  • Tablet. Ace

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
Changes in the amount of urinary paracetamol in different times
Time Frame: [Morning: 0 hour (baseline), 4 hour (end); Mid-day: 0 hour (baseline), 4 hour (end); Night: 0 hour (baseline), 4 hour (end)] [Safety Issue: No]
Changes in the amount of urinary paracetamol in different times (morning, midday and night) 4 hours after oral administration of 500 mg of paracetamol
[Morning: 0 hour (baseline), 4 hour (end); Mid-day: 0 hour (baseline), 4 hour (end); Night: 0 hour (baseline), 4 hour (end)] [Safety Issue: No]

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.
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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 (Actual)

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.
November 3, 2016

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.
January 30, 2018

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.
January 30, 2018

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).
April 17, 2017

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.
April 20, 2017

First Posted (Actual)

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.
April 21, 2017

Study Record Updates

Last Update Posted (Actual)

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.
July 13, 2018

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.
July 12, 2018

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.
July 1, 2018

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.
  • BSMMU-013-CT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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