Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation
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|ClinicalTrials.gov Identifier: NCT03777605|
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Angina Pectoris||Drug: Nitroglycerin 0.4 MG||Phase 4|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A randomized, cross over design|
|Masking:||None (Open Label)|
|Masking Description:||All tablets are processed, marked and coded by a pharmacist,|
|Official Title:||Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy|
|Estimated Study Start Date :||December 23, 2018|
|Estimated Primary Completion Date :||December 5, 2020|
|Estimated Study Completion Date :||December 23, 2020|
Experimental: "NTG1523", rapid absorbable capsule
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
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
Other Name: "NTG1523"
- Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls [ Time Frame: From 2 weeks up til 5 weeks ]Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine
- Blood pressure in response to Nitroglycerine [ Time Frame: From 2 weeks up til 5 weeks ]Blood pressure (mmHg)
- Puls rate in response to Nitroglycerine [ Time Frame: From 2 weeks up til 5 weeks ]puls rate (beat/min)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777605
|Contact: ole W Rasmussen, M.D., Dr.Sciemail@example.com|
|Contact: Poul H Madsen, M.D., Ph.D.||+45 76362000||Poul.Henning.Madsen@rsyd.dk|
|Kolfding Sygehus, SLB|
|Kolding, Denmark, 6000|
|Principal Investigator:||ole W Rasmussen, M.D. Dr.Sci||Medical Dept.,Kolding Hospital, SLB, Denmark|