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Para1523: Pharmacokinetic Study of Paracetamol.

Sponsor
Kolding Sygehus (Other)
Overall Status
Unknown status
CT.gov ID
NCT03953287
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
5.6
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Interventional (Clinical Trial)Interventional (Clinical Trial)
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.
Anticipated Study Start Date :
Aug 18, 2019
Anticipated Primary Completion Date :
Dec 5, 2019
Anticipated Study Completion Date :
Feb 3, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetic study of paracetamol [4 hours]

      Peak Plasma Concentration of paracetamol

    Secondary Outcome Measures

    1. Pharmacokinetic study of paracetamol [4 hours]

      Area under the response curve of Paracetamol

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Normal healthy volunteers

    • Must be able to swallow tablets

    Exclusion Criteria:

    • Diabetes

    • Thyroid disease

    • any medial treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kolfding Sygehus, SLB Kolding Denmark 6000

    Sponsors and Collaborators

    • Kolding Sygehus

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kolding Sygehus
    ClinicalTrials.gov Identifier:
    NCT03953287
    Other Study ID Numbers:
    • Paracetamol1523
    First Posted:
    May 16, 2019
    Last Update Posted:
    May 16, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Acetaminophen

    Study Results

    No Results Posted as of May 16, 2019