The bioavailability of Nicorandil in humans: A pilot study to investigate the variability of the pharmacokinetic parameters in healthy volunteers. The IMP Nicorandil (2-(pyridine-3-carbonylamino)ethyl nitrate) used in this pharmacokinetic study is approved for the treatment of coronary heart disease MedDRA version: 9.1 Level: LLT Classification code 10007649 Term: Cardiovascular disorder
Conditions
Interventions
Trade Name: Dancor
Product Name: Nicorandil
Pharmaceutical Form: Tablet
INN or Proposed INN: NICORANDIL
CAS Number: 65141460
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
Kwizda Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Caucasians between 18 and 55 years of age in general good physical health as determined by medical history, physical examination, 12-lead electrocardiogram, vital signs and clinical laboratory tests. Weight within the normal range according to accepted values for the Body Mass Index (BMI) within 18 to 27 kg/m². Normal blood pressure (Systolic Blood Pressure (SBP) >90, 60, =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Positive test for human immunodeficiency virus (HIV) antibodies. Positive hepatitis B surface antigen (HBsAg) test. Positive Anti-Hepatitits C virus (Anti-HCV) test. Female subjects with a positive pregnancy test (verified by human chorionic gonadotropin [ß-HCG]-urine test). Breast-feeding women. Demonstrating any active physical disease, acute or chronic. Subjects with seizure disorders. Subjects with active presence or history of alcoholism or drug addiction. More than moderate alcohol consumption (defined as more than 2 drinks per day). Any history or suspicion of barbiturate, benzodiazepine, amphetamine, cocaine, opiates, and cannabis abuse (verified by urinary drug test). More than moderate smoker (<10 cigarettes/day). Demonstrating excessive xanthine consumption (more than 5 cups of coffee or equivalent per day). Consumption of methylxanthine-containing food or beverages, grapefruit juice within 24 hours prior to administration. Vegetarians. Subjects with relevant drug hypersensitivity, asthma, urticaria or other severe allergic diathesis as well as current hay fever. Any history of hypersensitivity to the study drug. Subjects with active or a history of gastrointestinal disease. Any gastrointestinal complaints within seven days prior to dosing. Any history of chronic gastritis or peptic ulcers. Any relevant history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological (especially history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies, and bleeding tendency. Subjects who take prescribed medication or over-the-counter medication within two weeks prior to dosing (except for occasional paracetamol use and use of hormonal contraceptives). Participation in the treatment phase of a clinical study within 30 days prior to the treatment phase of this study. Blood donation within 30 days prior to inclusion in this study. Laboratory values outside the reference range, if clinically relevant (e.g., suggesting an unknown disease and requiring further clinical evaluation assessed by the investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Evaluation of the safety and tolerability of Nicorandil 20 mg in healthy male and female subjects.;Primary end point(s): PK target variables are: AUC0-tz, Cmax, tmax, AUC0-infinity, and t½el (pharmacokinetic variables will be calculated using non-compartmental methods). ;Main Objective: Investigation of the bioavailability of Nicorandil and the intrasubject variability of these parameters. | — |
Countries
Austria
Outcome results
None listed