Angina Pectoris
Conditions
Brief summary
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
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 .
Interventions
DRUGNitroglycerin 0.4 MG
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
Sponsors
Kolding Sygehus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
All tablets are processed, marked and coded by a pharmacist,
Intervention model description
A randomized, cross over design
Eligibility
Sex/Gender
ALL
Age
18 Years to 28 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal healthy volunteers * Must be able to swallow tablets
Exclusion criteria
* Insulin dependent diabetes * Thyroid disease * any medial treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule NTG1523 in young healthy controls | From 2 weeks up til 5 weeks | Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure in response to Nitroglycerine | From 2 weeks up til 5 weeks | Blood pressure (mmHg) |
| Puls rate in response to Nitroglycerine | From 2 weeks up til 5 weeks | puls rate (beat/min) |
Countries
Denmark
Contacts
Primary Contactole W Rasmussen, M.D., Dr.Sci
Backup ContactPoul H Madsen, M.D., Ph.D.
Outcome results
None listed