The bioavailability of nicorandil in humans: A pilot study to investigate the variability of its pharmacokinetic parameters in healthy volunteers.

Conditions: 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: 9.1Level: LLTClassification code 10007649Term: Cardiovascular disorder

Registration Number: EUCTR2008-005532-32-AT

Lead Sponsor: Kwizda Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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, <140 mm Hg; Diastolic Blood Pressure (DBP) >60, <100 mm Hg) measured after 5 min rest in supine position.
A heart rate at rest of 40 and 99 min-¹ measured after 5 min rest in supine position.
Electrocardiogram (ECG) recording without clinically significant abnormalities.
Having had no febrile or infectious illness for at least two weeks prior to the first administration of the investigational product of the study.
Women practicing one or a combination of the following methods of birth control: oral contraceptives, condoms, sponge, foams, jelly, diaphragm, or intrauterine device, or women who are surgically sterilized.
Subjects are able to communicate well with the investigator and are able to comply with the requirements of the entire study.
Subjects must voluntarily sign a written informed consent agreement approved by the Ethics Committee after explanation of the nature and objectives of the study and prior to any study specific procedure

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)