Angina Pectoris Clinical Trial
Official title:
Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy
The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine 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
Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an
overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an
anticubical vein for blood samples.
At 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523"
capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order.
Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the
following two hours. In addition, blood pressure and puls rate are measured every second
minute the first ten minutes, and then every 10 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 .
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