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Pharmacokinetics of Nicorandil 40 mg Extended-Release Capsules in Healthy Subjects Under Fasting and Fed Conditions.
EU CTIS ID: 2023-506085-31-00
What this study is testing
− To characterize and compare the pharmacokinetics of nicorandil and its metabolite N-(2-hydroxyethyl) nicotinamide following a single-dose administration of nicorandil 40 mg extended-release capsules under fasting and fed conditions. − To assess the effect of food on the pharmacokinetics of nicorandil and metabolite N-(2-hydroxyethyl) nicotinamide after single dose administration of nicorandil 40 mg extended-release capsules.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Free written informed consent signed and dated prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted, highly effective contraceptive method from at least 8 weeks prior to admission to the first study period until the end of the study.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
You likely can't join if
- Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
- SBP <95 mmHg and/or DBP <45 mmHg.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
See the full eligibility criteria
Who can join
- Free written informed consent signed and dated prior to any procedure required by the study.
- Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).
- Willingness to accept and comply with all study procedures and restrictions.
- A female subject is eligible if she meets the following criteria: a) Is of non-childbearing potential; or b) is of childbearing potential and agrees to use an accepted, highly effective contraceptive method from at least 8 weeks prior to admission to the first study period until the end of the study.
- Male or female subject between 18 and 55 years, inclusive, at the time of signing the informed consent.
- Body mass index (BMI) of 18.0 to 31.0 kg/m2, inclusive.
- No clinically relevant diseases captured in medical history.
- No clinically relevant abnormalities on physical examination.
- No clinically relevant abnormalities on vital signs.
- No clinically relevant abnormalities on 12-lead ECG.
- No clinically relevant abnormalities on laboratory tests.
- Negative test results for anti-Human Immunodeficiency virus 1 and 2 antibodies (anti-HIV-1Ab and anti-HIV-2Ab), Hepatitis B surface antigen (HbsAG) and anti-Hepatitis C virus antibodies (anti-HCVAb).
What rules you out
- Known hypersensitivity/allergy reaction to the study drug substance or any of the excipients.
- SBP <95 mmHg and/or DBP <45 mmHg.
- Serum transaminases alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range.
- Estimated renal creatinine clearance (CLCr) below the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m2.
- Positive result in drugs-of-abuse or ethanol tests.
- Use of a depot injection or an implant of any drug (except for contraceptives) within the previous 6 months.
- Average weekly alcohol consumption of >14 units for males and >7 units for females within the previous 6 months.
- Average daily consumption of methylxanthines-containing beverages or food (e.g., coffee, tea, cola, sodas, chocolate) equivalent to >500 mg of methylxanthines.
- Participation in any clinical trial within the previous 2 months.
- Participation in more than 2 clinical trials within the previous 12 months.
- Blood donation or significant blood loss (≥ 450 mL) due to any reason or had plasmapheresis within the previous 2 months.
- Known severe hypersensitivity reaction to any other drug.
- Difficulty in fasting or any dietary restriction such as lactose intolerance, vegan, low-fat, low sodium, etc., that may interfere with the diet served during the study.
- Veins unsuitable for intravenous puncture on either arm.
- Difficulty in swallowing capsules or tablets.
- If woman of childbearing potential (WOCBP), positive pregnancy test.
- If woman, she is breast-feeding.
- Any other condition that the Investigator considers to render the subject unsuitable for the study.
- Any recent disease or condition or treatment that, according to the Investigator, would put the subject at undue risk due to study participation or occurred at a timeframe in which may interfere with the pharmacokinetics of the study drug.
- Use of prescription or nonprescription medicinal products, such as vitamins, food supplements, or herbal supplements (including St John’s Wort), within the previous 2 weeks, unless in the Investigator’s opinion, the medication does not interfere with the pharmacokinetics of the study drug or compromise subject safety.
- Use of phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil) and/or soluble guanylate cyclase stimulants (riociguat) within the previous week.
- Positive result in drugs-of-abuse or ethanol tests.
- Any medical condition (e.g., gastrointestinal, renal or hepatic, including peptic ulcer, inflammatory bowel disease or pancreatitis) or surgical condition (e.g., cholecystectomy, gastrectomy) that may affect drug pharmacokinetics (absorption, distribution, metabolism or excretion) or subject’s safety.
- If WOCBP, positive or inconclusive pregnancy test.
- Any other condition that the Investigator considers to render the subject unsuitable for the study period.
- History of glucose-6-phosphate dehydrogenase deficiency.
- History of severe hypotension or shock.
- History of acute pulmonary edema, heart failure, coronary artery disease or myocardial infarction.
- History of orthostatic hypotension, collapse, fainting, syncope, or vasovagal reaction.
- History of substance or alcohol abuse within the previous 2 years.
- Use of contact lenses.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.