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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
Sponsor:
Information provided by (Responsible Party):
Ole Winther Rasmussen, Kolding Sygehus

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

Condition or disease Intervention/treatment Phase
Angina Pectoris Drug: Nitroglycerin 0.4 MG Phase 4

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 .


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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,
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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"




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Blood pressure in response to Nitroglycerine [ Time Frame: From 2 weeks up til 5 weeks ]
    Blood pressure (mmHg)

  2. Puls rate in response to Nitroglycerine [ Time Frame: From 2 weeks up til 5 weeks ]
    puls rate (beat/min)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal healthy volunteers
  • Must be able to swallow tablets

Exclusion Criteria:

  • Insulin dependent diabetes
  • Thyroid disease
  • any medial treatment

Information from the National Library of Medicine

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


Contacts
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Contact: ole W Rasmussen, M.D., Dr.Sci +4550506930 olew.rasmussen@dadlnet.dk
Contact: Poul H Madsen, M.D., Ph.D. +45 76362000 Poul.Henning.Madsen@rsyd.dk

Locations
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Denmark
Kolfding Sygehus, SLB
Kolding, Denmark, 6000
Sponsors and Collaborators
Kolding Sygehus
Investigators
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Principal Investigator: ole W Rasmussen, M.D. Dr.Sci Medical Dept.,Kolding Hospital, SLB, Denmark

Publications of Results:
Other Publications:
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Responsible Party: Ole Winther Rasmussen, Clinical professor, Kolding Sygehus
ClinicalTrials.gov Identifier: NCT03777605     History of Changes
Other Study ID Numbers: Nitroglycerine1523 (NTG1523)
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Nitroglycerin
Vasodilator Agents