Pharmacokinetic Study of Paracetamol.
Para1523
Pharmacokinetic/Pharmacodynamic Study of Paracetamol Taken as an Oral Chewing Capsule Versus Normal Tablet in Healthy Young Men.
1 other identifier
interventional
12
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2019
CompletedFirst Posted
Study publicly available on registry
May 16, 2019
CompletedStudy Start
First participant enrolled
August 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 3, 2020
CompletedMay 16, 2019
May 1, 2019
4 months
May 13, 2019
May 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic study of paracetamol
Peak Plasma Concentration of paracetamol
4 hours
Secondary Outcomes (1)
Pharmacokinetic study of paracetamol
4 hours
Study Arms (1)
Pharmacokinetic Study of Paracetamol.
EXPERIMENTALDetailed 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 .
Interventions
A randomized, cross over design
Eligibility Criteria
You may qualify if:
- Normal healthy volunteers
- Must be able to swallow tablets
You may not qualify if:
- Diabetes
- Thyroid disease
- any medial treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kolding Sygehuslead
Study Sites (1)
Kolfding Sygehus, SLB
Kolding, 6000, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ole Rasmussen, M.D.
Medical Dept.,Kolding Hospital, SLB, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2019
First Posted
May 16, 2019
Study Start
August 18, 2019
Primary Completion
December 5, 2019
Study Completion
February 3, 2020
Last Updated
May 16, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share