Pharmacological ActionPhase 1Para1523NCT03953287
Pharmacokinetic Study of Paracetamol.
A Phase 1 study testing Paracetamol in people with Pharmacological Action, run by Kolding Sygehus at 1 site in Denmark.
Trial summary
Brief Summary: The study evaluate the absorption rate and pharmacodynamic of different formulation of paracetamol either in the form of normal tablets or a new rapid absorbable gelation capsule formulation "Paracetamol1523" by determining T-max and area under the response curve of paracetamol in blood concentration as… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacological Action
- What is being tested?
- Paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Aug 2019to 3 Feb 2020
- Phase
- Phase 1
- 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal healthy volunteers
- Must be able to swallow tablets
Who cannot join
- Diabetes
- Thyroid disease
- any medial treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.
Brief Summary:
The study evaluate the absorption rate and pharmacodynamic of different formulation of paracetamol either in the form of normal tablets or a new rapid absorbable gelation capsule formulation "Paracetamol1523" by determining T-max and area under the response curve of paracetamol in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Read the detailed description
Detailed Description:
Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. Clinical data are recorded and a catheter is inserted in an antecubital vein for blood samples.
At 08.00 paracetamol (500 mg) taken as tablet or a "Paracetamol1523" c in random order. Subsequently, blood samples are taken every 3 minute for one hour minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 10 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.
The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 4 hours in which blood samples are taken as described above, and blood pressure and records are stored .
- Conditions
- Pharmacological Action
- Being tested
- Paracetamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Paracetamol1523
A randomized, cross over design
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic Study of Paracetamol. | Experimental | Detailed Description:
Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. BMI and blod pressure are recorded and a catheter is inserted in an antecubital vein for blood samples.
At 08.00 participants take 500 mg paracetamol as a tablet with 200 ml tap water or a "Paracetamol1523" capsule in random order. Subsequently, blood samples are taken every minute for 3 minutes the first hour, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 20 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.
The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored . Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic study of paracetamol
Peak Plasma Concentration of paracetamol
Measured: 4 hours
Secondary outcomes (1)
Pharmacokinetic study of paracetamol
Area under the response curve of Paracetamol
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start18 Aug 2019 (estimated)
- Primary completion5 Dec 2019 (estimated)
- Study completion3 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacological ActionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional (Clinical Trial)
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kolding Sygehus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ole Rasmussen, M.D., Principal investigator, Medical Dept.,Kolding Hospital, SLB, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953287
- Sponsor's protocol ID
- Paracetamol1523
- Acronym
- Para1523
- Status last verified
- May 2019
- First submitted
- 13 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.
- ClinicalTrials.gov ID
- NCT03953287
- Acronym / sponsor ID
- Para1523 / Paracetamol1523
- Conditions
- Pharmacological Action
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Kolding SygehusUniversity, hospital or other
- Study start
- 18 Aug 2019 (estimated)
- Primary completion
- 5 Dec 2019 (estimated)
- Study completion
- 3 Feb 2020 (estimated)
- First posted
- 16 May 2019 (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.
Brief Summary:
The study evaluate the absorption rate and pharmacodynamic of different formulation of paracetamol either in the form of normal tablets or a new rapid absorbable gelation capsule formulation "Paracetamol1523" by determining T-max and area under the response curve of paracetamol in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant's rights in a biomedical research project
Detailed description
Detailed Description:
Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. Clinical data are recorded and a catheter is inserted in an antecubital vein for blood samples.
At 08.00 paracetamol (500 mg) taken as tablet or a "Paracetamol1523" c in random order. Subsequently, blood samples are taken every 3 minute for one hour minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 10 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.
The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 4 hours in which blood samples are taken as described above, and blood pressure and records are stored .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional (Clinical Trial)
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic Study of Paracetamol. | Experimental | Drug: ParacetamolDetailed Description: Twelve healthy young volunteers are recruited, and the experiments begin at 07:45 after an overnight fast. BMI and blod pressure are recorded and a catheter is inserted in an antecubital vein for blood samples. At 08.00 participants take 500 mg paracetamol as a tablet with 200 ml tap water or a "Paracetamol1523" capsule in random order. Subsequently, blood samples are taken every minute for 3 minutes the first hour, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every 20 minute the first hour, and then every 30 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme. The disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Normal healthy volunteers
- Must be able to swallow tablets
Key exclusion criteria (3 listed)
- Diabetes
- Thyroid disease
- any medial treatment
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 |
|---|---|---|
| ParacetamolAlso: Paracetamol1523A randomized, cross over design | Drug | Pharmacokinetic Study of Paracetamol. |
Primary outcome
Pharmacokinetic study of paracetamol
Time frame: 4 hours
Peak Plasma Concentration of paracetamol
1 secondary outcome
Pharmacokinetic study of paracetamol
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2019.
- Individual participant dataSharing planned: No
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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.
ole Rasmussen, M.D. principal investigator
Medical Dept.,Kolding Hospital, SLB, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Paracetamol in people with Pharmacological Action, run by Kolding Sygehus at 1 site in Denmark.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 May 2019. 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 Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact OLE W RASMUSSEN, M.D., Dr.Sci (+4550506930, olew.rasmussen@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic study of paracetamol (time frame: 4 hours). 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 16 May 2019.