Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation

Phase 4

• Conditions: Angina Pectoris
• Interventions: Drug: Nitroglycerin 0.4 MG

• Registration Number: NCT03777605
• Lead Sponsor: 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

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 Timeline

• Status Verified: 2018-12
• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19
• Study Start: 2018-12-23
• Primary Completion: 2020-12-05
• Study Completion: 2020-12-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Normal healthy volunteers
• Must be able to swallow tablets

Exclusion Criteria

• Insulin dependent diabetes
• Thyroid disease
• any medial treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
"NTG1523", rapid absorbable capsule	Nitroglycerin 0.4 MG	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

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls	From 2 weeks up til 5 weeks	Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine

Secondary Outcome Measures

Name	Time	Method
Blood pressure in response to Nitroglycerine	From 2 weeks up til 5 weeks	Blood pressure (mmHg)
Puls rate in response to Nitroglycerine	From 2 weeks up til 5 weeks	puls rate (beat/min)

Trial Locations

Locations (1)

Kolfding Sygehus, SLB; 🇩🇰 Kolding, Denmark