Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation

Study Overview
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Brief Summary
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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

Detailed Description
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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 .

Official Title
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Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy

Conditions
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Angina Pectoris

Intervention / Treatment
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* Drug: Nitroglycerin 0.4 MG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal healthy volunteers Must be able to swallow tablets Exclusion Criteria: Insulin dependent diabetes Thyroid disease any medial treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: A randomized, cross over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NTG1523, rapid absorbable capsule<br>Nitroglycerine 0.4 milligram taken as ordinary tablets or NTG1523 rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed | Drug: Nitroglycerin 0.4 MG<br>* The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel NTG1523 determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects. 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<br>* Other names: NTG1523;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule NTG1523 in young healthy controls | Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine | From 2 weeks up til 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure in response to Nitroglycerine | Blood pressure (mmHg) | From 2 weeks up til 5 weeks | 
| Puls rate in response to Nitroglycerine | puls rate (beat/min) | From 2 weeks up til 5 weeks |