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Pharmacokinetic Study of Paracetamol.

Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03953287
Acronym
Para1523
Enrollment
12
Registered
2019-05-16
Start date
2019-08-18
Completion date
2020-02-03
Last updated
2019-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacological Action

Brief 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 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 .

Interventions

DRUGParacetamol

A randomized, cross over design

Sponsors

Kolding Sygehus
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Interventional (Clinical Trial)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Normal healthy volunteers * Must be able to swallow tablets

Exclusion criteria

* Diabetes * Thyroid disease * any medial treatment

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetic study of paracetamol4 hoursPeak Plasma Concentration of paracetamol

Secondary

MeasureTime frameDescription
Pharmacokinetic study of paracetamol4 hoursArea under the response curve of Paracetamol

Countries

Denmark

Contacts

Primary ContactOLE W RASMUSSEN, M.D., Dr.Sci
olew.rasmussen@dadlnet.dk+4550506930
Backup ContactMette W Loekke, Nurse
Mette.loekke@rsyd.dk+ 45 76362142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026