NCT03953287

Pharmacokinetic Study of Paracetamol.

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Kolding Sygehus · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 .

Conditions

• Pharmacological Action

Interventions

Type	Name	Description
DRUG	Paracetamol	A randomized, cross over design

Timeline

• Start date: 2019-08-18
• Primary completion: 2019-12-05
• Completion: 2020-02-03
• First posted: 2019-05-16
• Last updated: 2019-05-16

Locations

1 site across 1 country: Denmark