Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation

Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03777605
• Other study ID #: Nitroglycerine1523 (NTG1523)
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 23, 2018
• Est. completion date: December 23, 2020

Study information

• Verified date: December 2018
• Source: Kolding Sygehus
• Contact: ole W Rasmussen, M.D., Dr.Sci
• Phone: +4550506930
• Email: olew.rasmussen[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 23, 2020
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

Inclusion Criteria:

• Normal healthy volunteers

• Must be able to swallow tablets

Exclusion Criteria:

• Insulin dependent diabetes

• Thyroid disease

• any medial treatment

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

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

Locations

Country	Name	City	State
Denmark	Kolfding Sygehus, SLB	Kolding

Sponsors (1)

Lead Sponsor	Collaborator
Kolding Sygehus

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood pressure in response to Nitroglycerine	Blood pressure (mmHg)	From 2 weeks up til 5 weeks
Secondary	Puls rate in response to Nitroglycerine	puls rate (beat/min)	From 2 weeks up til 5 weeks