In short
Nicorandil is a medicine used to treat angina, a type of chest pain caused by reduced blood flow to the heart. It is available as tablets and is also being studied in an extended-release capsule form. One completed Phase 1 trial with 16 healthy participants investigated how a 40 mg extended-release capsule is absorbed by the body under fasting and fed conditions.
Key points
- Phase 1 trial completed with 16 healthy participants.
- Study tested 40 mg extended-release capsules of nicorandil.
- Trial compared fasting and fed conditions to assess food effects.
- Primary outcomes measured pharmacokinetic parameters such as Cmax and AUC.
- Nicorandil is authorised as 10 mg and 20 mg tablets for angina.
- Registered trial identifier: 2023-506085-31-00.
What is nicorandil?
Nicorandil is a medicine used to treat angina, a type of chest pain that occurs when the heart muscle does not get enough blood and oxygen. It is authorised as a medicine in the United Kingdom, where it is available as 10 mg and 20 mg tablets. The brand name Ikorel appears among the available products. The clinical trial listed on this page used an extended-release capsule formulation of nicorandil at a 40 mg strength, which differs from the authorised tablet forms.
How does nicorandil work?
Nicorandil has a dual mechanism of action. It acts as a potassium channel opener, which relaxes the smooth muscle in blood vessels, and it also has nitrate-like properties that widen veins and reduce the workload on the heart. This combination helps to improve blood flow to the heart muscle and relieve the symptoms of angina. The pharmacokinetic study measured nicorandil and its metabolite N-(2-hydroxyethyl) nicotinamide to understand how the body processes the extended-release formulation.
Which conditions is nicorandil used or studied for?
- Angina — nicorandil is authorised for the treatment of this chest pain condition caused by reduced blood flow to the heart.
- No medical condition — the Phase 1 trial enrolled healthy participants to study the pharmacokinetics of the extended-release capsule, not to treat a disease.
How is nicorandil given?
Nicorandil is available as tablets for oral use, in strengths of 10 mg and 20 mg. The clinical trial investigated a different formulation: 40 mg extended-release capsules taken by mouth. The study compared how the body absorbs the capsule when taken on an empty stomach (fasting) versus after a meal (fed).
What do the clinical trials show?
One Phase 1 trial has been completed for the extended-release capsule formulation. The trial enrolled 16 healthy participants and was designed to compare the pharmacokinetics of a single 40 mg dose under fasting and fed conditions. The main purpose was to characterise how the body absorbs, distributes, metabolises and eliminates nicorandil and its metabolite, and to assess the effect of food on this process.
What is measured?
The primary outcomes are pharmacokinetic parameters, which describe how the drug moves through the body. These include Cmax (the highest concentration of the drug in the blood), AUC0-t and AUC0-∞ (the total exposure to the drug over time), Tmax (the time to reach the highest concentration), Tlag (the delay before the drug appears in the blood), λz (the elimination rate constant), t1/2 (the half-life, or time for the drug concentration to fall by half), CL/F (apparent clearance), Vz/F (apparent volume of distribution), and MRCmax and MRAUC0-t (metabolite-to-parent ratios for Cmax and AUC).
Who can take part?
The trial enrolled healthy subjects with no medical condition, which is typical for Phase 1 pharmacokinetic studies. The study is now completed, so it is no longer recruiting participants.
What side effects are known?
The supplementary sources provided for this page do not list side effects for nicorandil. The Phase 1 trial summary does not report adverse events.