Pharmacokinetic Study of Paracetamol.

Pharmacological Action Clinical Trial

— Para1523  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03953287
• Other study ID #: Paracetamol1523
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: August 18, 2019
• Est. completion date: February 3, 2020

Study information

• Verified date: May 2019
• Source: Kolding Sygehus
• Contact: OLE W RASMUSSEN, M.D., Dr.Sci
• Phone: +4550506930
• Email: olew.rasmussen[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: February 3, 2020
• Est. primary completion date: December 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Normal healthy volunteers

• Must be able to swallow tablets

Exclusion Criteria:

• Diabetes

• Thyroid disease

• any medial treatment

Related Conditions & MeSH terms

• Pharmacological Action

Intervention

Drug:
• Paracetamol
A randomized, cross over design

Locations

Country	Name	City	State
Denmark	Kolfding Sygehus, SLB	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic study of paracetamol	Peak Plasma Concentration of paracetamol	4 hours
Secondary	Pharmacokinetic study of paracetamol	Area under the response curve of Paracetamol	4 hours