Pharmacokinetic Study of Paracetamol.

Phase 1

• Conditions: Pharmacological Action
• Interventions: Drug: Paracetamol

• Registration Number: NCT03953287
• Lead Sponsor: Kolding Sygehus

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 .

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-15
• Last Update Submitted: 2019-05-15
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16
• Study Start: 2019-08-18
• Primary Completion: 2019-12-05
• Study Completion: 2020-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Normal healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria

• Diabetes
• Thyroid disease
• any medial treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pharmacokinetic Study of Paracetamol.	Paracetamol	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 .

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic study of paracetamol	4 hours	Peak Plasma Concentration of paracetamol

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic study of paracetamol	4 hours	Area under the response curve of Paracetamol

Trial Locations

Locations (1)

Kolfding Sygehus, SLB; 🇩🇰 Kolding, Denmark