Pharmacological Action Clinical Trial
Official title:
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
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 .
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