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Pharmacokinetic Study of Paracetamol. (Para1523)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953287
Recruitment Status : Unknown
Verified May 2019 by Kolding Sygehus.
Recruitment status was:  Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kolding Sygehus

Study Description
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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
Pharmacological Action Drug: Paracetamol 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Estimated Study Start Date : August 18, 2019
Estimated Primary Completion Date : December 5, 2019
Estimated Study Completion Date : February 3, 2020
Arms and Interventions
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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 Name: Paracetamol1523


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic study of paracetamol [ Time Frame: 4 hours ]
    Peak Plasma Concentration of paracetamol


Secondary Outcome Measures :
  1. Pharmacokinetic study of paracetamol [ Time Frame: 4 hours ]
    Area under the response curve of Paracetamol


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy volunteers
  • Must be able to swallow tablets

Exclusion Criteria:

  • Diabetes
  • Thyroid disease
  • any medial treatment
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953287


Contacts
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Contact: OLE W RASMUSSEN, M.D., Dr.Sci +4550506930 olew.rasmussen@dadlnet.dk
Contact: Mette W Loekke, Nurse + 45 76362142 Mette.loekke@rsyd.dk

Locations
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Denmark
Kolfding Sygehus, SLB
Kolding, Denmark, 6000
Sponsors and Collaborators
Kolding Sygehus
Investigators
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Principal Investigator: ole Rasmussen, M.D. Medical Dept.,Kolding Hospital, SLB, Denmark
More Information
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Responsible Party: Kolding Sygehus
ClinicalTrials.gov Identifier: NCT03953287    
Other Study ID Numbers: Paracetamol1523
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics