Diurnal Variation of Paracetamol ExcretionNCT03122561
Estimation of Paracetamol in Urine to Assess the Diurnal Variation
A study testing Paracetamol 500 mg tablet at morning, Paracetamol 500 mg tablet at midday and Paracetamol 500 mg tablet at night in people with Diurnal Variation of Paracetamol Excretion, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diurnal Variation of Paracetamol Excretion
- What is being tested?
- Paracetamol 500 mg tablet at morning, Paracetamol 500 mg tablet at midday and Paracetamol 500 mg tablet at night
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteBangladesh
- Study dates
- 3 Nov 2016to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The healthy male student volunteers of Eastern Medical College having age range between 19 and 23 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Paracetamol 500 mg tablet at morning, Paracetamol 500 mg tablet at midday, Paracetamol 500 mg tablet at night
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paracetamol 500 mg tablet at morningDrug
Also called Tablet. Ace
Single dose oral paracetamol will be administered at 8.00 am
Paracetamol 500 mg tablet at middayDrug
Also called Tablet. Ace
Single dose oral paracetamol will be administered at 2.00 pm
Paracetamol 500 mg tablet at nightDrug
Also called Tablet. Ace
Single dose oral paracetamol will be administered at 8.00 pm
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol 500 mg tablet at Morning | Other | Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at morning Receives: Drug: Paracetamol 500 mg tablet at morning |
| Paracetamol 500 mg tablet at Midday | Other | Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at midday Receives: Drug: Paracetamol 500 mg tablet at midday |
| Paracetamol 500 mg tablet at Night | Other | Urinary paracetamol of 41 healthy volunteers will be measured after oral administration at night Receives: Drug: Paracetamol 500 mg tablet at night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the amount of urinary paracetamol in different times
Changes in the amount of urinary paracetamol in different times (morning, midday and night) 4 hours after oral administration of 500 mg of paracetamol
Measured: [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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start3 Nov 2016
- Primary completion30 Jan 2018
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diurnal Variation of Paracetamol ExcretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy Volunteers
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Mir Misbahuddin, PhD, Study director, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03122561
- Sponsor's protocol ID
- BSMMU-013-CT
- Status last verified
- Jul 2018
- First submitted
- 17 Apr 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Paracetamol in Urine to Assess the Diurnal Variation
- ClinicalTrials.gov ID
- NCT03122561
- Acronym / sponsor ID
- BSMMU-013-CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 3 Nov 2016 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Healthy Volunteers
| Arm | Type | Receives |
|---|---|---|
| Paracetamol 500 mg tablet at Morning | Other | Drug: Paracetamol 500 mg tablet at morningUrinary paracetamol of 41 healthy volunteers will be measured after oral administration at morning |
| Paracetamol 500 mg tablet at Midday | Other | Drug: Paracetamol 500 mg tablet at middayUrinary paracetamol of 41 healthy volunteers will be measured after oral administration at midday |
| Paracetamol 500 mg tablet at Night | Other | Drug: Paracetamol 500 mg tablet at nightUrinary paracetamol of 41 healthy volunteers will be measured after oral administration at night |
Who may qualify
- Ages
- 19 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The healthy male student volunteers of Eastern Medical College having age range between 19 and 23 years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paracetamol 500 mg tablet at morningAlso: Tablet. AceSingle dose oral paracetamol will be administered at 8.00 am | Drug | Paracetamol 500 mg tablet at Morning |
| Paracetamol 500 mg tablet at middayAlso: Tablet. AceSingle dose oral paracetamol will be administered at 2.00 pm | Drug | Paracetamol 500 mg tablet at Midday |
| Paracetamol 500 mg tablet at nightAlso: Tablet. AceSingle dose oral paracetamol will be administered at 8.00 pm | Drug | Paracetamol 500 mg tablet at Night |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mir Misbahuddin, PhD study director
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paracetamol 500 mg tablet at morning, Paracetamol 500 mg tablet at midday and Paracetamol 500 mg tablet at night in people with Diurnal Variation of Paracetamol Excretion, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.