Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation
NCT ID: NCT03777605
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
10 participants
INTERVENTIONAL
2018-12-23
2020-12-23
Brief Summary
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Detailed Description
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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 .
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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"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
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to swallow tablets
Exclusion Criteria
* Thyroid disease
* any medial treatment
18 Years
28 Years
ALL
Yes
Sponsors
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Kolding Sygehus
OTHER
Responsible Party
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Ole Winther Rasmussen
Clinical professor
Principal Investigators
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ole W Rasmussen, M.D. Dr.Sci
Role: PRINCIPAL_INVESTIGATOR
Medical Dept.,Kolding Hospital, SLB, Denmark
Locations
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Kolfding Sygehus, SLB
Kolding, , Denmark
Countries
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Central Contacts
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References
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Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.
McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.
Other Identifiers
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Nitroglycerine1523 (NTG1523)
Identifier Type: -
Identifier Source: org_study_id