Pharmacokinetics of Nicorandil 40 mg Extended‑Release Capsules in Healthy Volunteers Under Fasting and Fed Conditions

1 1 1

What is this study about?

The study examines how the body handles a single dose of Nicorandil 40 mg formulated as an extended-release capsule. This medication is taken by mouth and is designed to release the drug slowly over time. The trial enrolls healthy volunteers who do not have any known medical condition.

The purpose is to characterize and compare the pharmacokinetics of the drug and its breakdown product N-(2-hydroxyethyl) nicotinamide when the dose is taken under fasting conditions and after a meal (fed conditions). Participants receive the capsule once, then later receive the same capsule under the opposite condition, allowing each person to serve as their own comparison. Throughout the study, vital signs, heart rhythm checks, and laboratory tests are performed, and any side effects that appear are recorded.

1 randomization and sequence assignment

after joining the study, you are randomly placed into one of two groups. each group receives the medication in a different order: either first under fasting conditions and then under fed conditions, or the opposite. this random order is called the study sequence.

2 first dosing period (fasting or fed)

on the scheduled day, follow the condition assigned to you. if the fasting condition is assigned, you must not eat or drink anything except water for at least eight hours before taking the medication. if the fed condition is assigned, you will eat a standardized meal before dosing.

take one nicorandil extended-release capsule containing 40 mg of the drug by mouth with a small amount of water. this is a single dose; no additional doses are taken on that day.

remain in the clinic for a monitoring period. during this time, staff will take several blood samples to measure how the drug is processed in your body and will check vital signs such as blood pressure and heart rate.

3 washout period

after the first dosing day, you will wait for a washout period, typically about one week, to allow the drug to leave your system completely. no study medication is taken during this time.

4 second dosing period (opposite condition)

on the second scheduled day, you receive the opposite condition from the first period. if you previously fasted, you will now eat the standardized meal before dosing; if you previously ate, you will now fast for at least eight hours.

again, take one 40 mg nicorandil extended-release capsule by mouth with water. this is also a single dose.

stay in the clinic for the same monitoring period as before, with blood samples taken at scheduled times and vital signs checked.

5 final assessments and study completion

after the second dosing day, staff will review any side effects you experienced, repeat vital sign measurements, and complete any final laboratory tests.

once all assessments are finished, the study procedures are complete.

Who Can Join the Study?

Signed a free written informed consent form and dated it before any study procedures (this means you understand the study and agree to take part).
Do not use tobacco or nicotine products, or have stopped using them for at least 3 months before the screening (non‑smoker or ex‑smoker).
Agree to follow all study procedures and any restrictions that are required.
If you are female, you must either be unable to become pregnant, or if you can become pregnant you must agree to use a highly effective birth‑control method starting at least 8 weeks before the first study period and continue until the study ends.
Be between 18 and 55 years old (inclusive) at the time you sign the consent form.
Have a body mass index (BMI) between 18.0 and 31.0 kg/m² (BMI is a simple calculation that relates your weight to your height).
Have no important medical conditions in your medical history that could affect the study.
Have no important findings on a physical examination.
Have normal vital signs such as blood pressure and heart rate (no important abnormalities).
Have a normal 12‑lead ECG (a test that records the electrical activity of the heart).
Have normal results on routine laboratory tests (no important abnormalities).
Test negative for infections: HIV antibodies, Hepatitis B surface antigen, and Hepatitis C antibodies (these tests check for specific viruses).

Who Cannot Join the Study?

Allergy to the study drug or any of its ingredients – you cannot take part if you are known to have a hypersensitivity (allergic) reaction to nicorandil or any substance used in the capsule.
Very low blood pressure – if your systolic blood pressure (the top number) is less than 95 mmHg or your diastolic blood pressure (the bottom number) is less than 45 mmHg.
Elevated liver enzymes – if blood tests show that alanine aminotransferase (ALT) or aspartate aminotransferase (AST) are above the normal range, indicating possible liver problems.
Poor kidney function – if your estimated creatinine clearance (a measure of kidney filtering ability calculated with the Cockcroft‑Gault formula) is below the normal lower limit.
Positive drug or alcohol test – if tests detect illegal drugs or recent alcohol use.
Recent long‑acting medication injection or implant – if you have received a depot injection or implanted drug (other than contraceptives) in the past 6 months.
High alcohol consumption – drinking more than 14 units per week for men or more than 7 units per week for women in the past 6 months.
Heavy caffeine intake – consuming more than about 500 mg of caffeine (found in coffee, tea, cola, sodas, chocolate, etc.) each day.
Recent participation in other clinical studies – if you have been in any clinical trial in the past 2 months.
Too many recent clinical studies – if you have taken part in more than two clinical trials in the past 12 months.
Recent blood donation or large blood loss – donating at least 450 mL of blood or having a procedure called plasmapheresis within the past 2 months.
Severe allergy to any other medication – known history of a serious hypersensitivity reaction to drugs other than the study drug.
Difficulty fasting or special diet restrictions – if you cannot fast or have dietary restrictions (e.g., lactose intolerance, vegan, low‑fat, low‑sodium) that would interfere with the study meals.
Inadequate veins for blood draws – if veins in both arms are not suitable for inserting an intravenous needle.
Problems swallowing capsules – if you have difficulty swallowing pills or capsules.
Pregnancy – if you are a woman who could become pregnant and test positive for pregnancy.
Breast‑feeding – if you are currently nursing a baby.
Any condition the doctor feels makes you unsuitable – the investigator may decide you are not appropriate for the study for any reason.
Recent illness or treatment that could affect safety or drug behavior – any disease, condition, or therapy that might put you at risk or change how the drug works.
Use of vitamins, supplements, or herbal products within 2 weeks – unless the doctor believes they will not interfere with the study drug.
Use of certain heart medications – taking phosphodiesterase‑5 inhibitors (such as sildenafil, tadalafil, vardenafil) or soluble guanylate cyclase stimulants (such as riociguat) within the past week.
Medical problems that could affect drug absorption or safety – conditions affecting the stomach, intestines, kidneys, liver, or past surgeries (like gallbladder removal or stomach surgery) that might change how the drug is processed.
Glucose‑6‑phosphate dehydrogenase (G6PD) deficiency – a hereditary enzyme deficiency that can cause red‑blood‑cell problems with certain drugs.
History of severe low blood pressure or shock – past episodes of very low blood pressure or circulatory collapse.
History of serious heart problems – such as acute pulmonary edema (fluid in the lungs), heart failure, coronary artery disease, or a heart attack (myocardial infarction).
History of fainting or drops in blood pressure when standing – includes orthostatic hypotension, collapse, fainting (syncope), or vasovagal reactions.
Recent substance or alcohol abuse – misuse of drugs or alcohol within the past 2 years.
Use of contact lenses – wearing contact lenses during the study period.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Beqlapweekfh Ikqopymumket E Dpxasxdvsdplfme Ei Snhxt Lmay	Porto	Portugal

Trial status

Country	Status	Recruitment Start
Portugal	Not recruiting	01.11.2023

Trial locations

Nicorandil is a medication taken by mouth in the form of a prolonged‑release capsule. In this study, a single dose was given to healthy volunteers to see how the drug and its breakdown product move through the body. The researchers looked at how quickly it is absorbed, how long it stays in the bloodstream, and how food might change these processes. This helps scientists understand the best way to use the medicine and how meals could affect its action.

Trial ID:

2023-506085-31-00

Protocol code:

AUX-PNI19-PK01

Trial Phase:

Human Pharmacology (Phase I) – Other

Other Trials to Consider

#1 Clinical Trials Search in Europe

Pharmacokinetics of Nicorandil 40 mg Extended‑Release Capsules in Healthy Volunteers Under Fasting and Fed Conditions

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?