Pharmacokinetic Study of Paracetamol. (Para1523)

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

Study Overview

• Status: Unknown
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: Paracetamol

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Kolfding Sygehus, SLB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Normal healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria:

• Diabetes
• Thyroid disease
• any medial treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pharmacokinetic Study of 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 .

Drug: Paracetamol; A randomized, cross over design; Other Names: Paracetamol1523

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic study of paracetamol	Peak Plasma Concentration of paracetamol	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic study of paracetamol	Area under the response curve of Paracetamol	4 hours

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Investigators: Principal Investigator: ole Rasmussen, M.D., Medical Dept.,Kolding Hospital, SLB, Denmark

Study record dates

Study Major Dates

• Study Start (Anticipated): August 18, 2019
• Primary Completion (Anticipated): December 5, 2019
• Study Completion (Anticipated): February 3, 2020

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: Paracetamol1523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No