Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation

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

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

Study Overview

• Status: Unknown
• Conditions: Angina Pectoris
• Intervention / Treatment: Drug: Nitroglycerin 0.4 MG

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 .

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: OLE W RASMUSSEN, M.D., Dr.Sci; Phone Number: +4550506930; Email: olew.rasmussen@dadlnet.dk
• Study Contact Backup: Name: Poul H Madsen, M.D., Ph.D.; Phone Number: +45 76362000; Email: Poul.Henning.Madsen@rsyd.dk

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Kolfding Sygehus, SLB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Normal healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria:

• Insulin dependent diabetes
• Thyroid disease
• any medial treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: "NTG1523"

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kolding Sygehus
• Investigators: Principal Investigator: ole W Rasmussen, M.D. Dr.Sci, Medical Dept.,Kolding Hospital, SLB, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 23, 2018
• Primary Completion (Anticipated): December 5, 2020
• Study Completion (Anticipated): December 23, 2020

Study Registration Dates

• First Submitted: December 3, 2018
• First Submitted That Met QC Criteria: December 13, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: Nitroglycerine1523 (NTG1523)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No