Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Age at 18-45 years (inclusive)
Male or Non-pregnant, non-lactating women
Chinese healthy subjects
Body mass index (BMI) at 19-24 kg/m2 (inclusive) and body weight at 50-100kg
Lab examinations (include but not limited: Hemoglobin, white blood cell counting, differential count, creatinine,Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT),Total bilirubin and urinalysis) are within normal range or out of normal range but no clinical significance.
Vital signs in screening phase: SBP100-139mmHg, DBP 50-89 mmHg, pulse rate 45-90 bpm. Holter is within normal range or out of normal range but no clinical significance.
Both physical examination and ECG at baseline are normal or abnormal but no clinical significance
Women of childbearing age during the trial must be willing to use a medically acceptable method of contraception, which include surgical sterilization (tubal ligation / hysterectomy), and double barrier methods of hormonal contraception.
Subjects well communicate with investigators, understanding the requirements of investigators and being willing to sign the ICF before conducting any study-related procedure.
Subjects are willing to stay at the phase I ward throughout the study.

Exclusion Criteria:

Disease history in liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal tract, lungs, immune, skin, blood, or metabolic disorders or cancer, that may have great impact on the study results.
Presence of pancreatitis, intestinal obstruction, glaucoma, prostatic hypertrophy, adrenal disease, hyperthyroidism or gallbladder disease (subjects had experienced cholecystectomy will not be excluded)
History of clinical significant disease in the past 4 weeks before screening visit
Presence of diseases which are known to disturb the absorption, distribution, metabolism or excretion of Istaroxime
Physical examinations, medical history, ECG, vital signs or lab examination are deemed to be abnormal and clinical significant
Be intolerant or allergy to Istaroxime, lactose or any similar substances
Significantly abnormal diets are conducted within 4 weeks before screening visit
Blood donation or loss equal to or exceeds 400ml in the past 6 months
Participating in the any other drug study in the past 3 months
Administrated OTC drugs including vitamin supplements and herbal (Occasional use of paracetamol will not be excluded)
Regular use of any prescription drug (Hormonal birth control pills or hormone replacement therapy will not be excluded)
Drinking beverage or eat food containing caffeinated / xanthine or poppy seed since 48 hours before study drugs administration; or drinking beverage or eat food containing grapefruit, oranges or Chinese tea 14 days before the study drug administration
Receiving the therapy of drugs including cytochrome P450 3A4 or cytochrome P450 2C8 inhibitors or inducers (eg barbiturates, carbamazepine, erythromycin, phenytoin, thiazoline TZDs, Rifampin)
Women at Lactation period or with positive pregnancy test
Tongue piercing or lip piercing occurred 30 days before the study drug administration
Smoke or tobacco is used 60 days before the study drug administration
History of abusing any substance including infusion drugs, alcohol and opium
Positive alcohol breathing test within 1day or drink alcohol within 1week
Abusing drugs (include Opioids, oxycodone, methamphetamine, amphetamine, cannabinoids, cocaine, barbiturates, benzodiazepines class, methadone, buprenorphine and phencyclidine)
History of heart disease
Planning to be pregnant in the recent 3 months
Participating any other interventional strudy in the past 30 days
History of bronchial asthma or blood porphyria disease
HbsAg, anti-HCV, anti-HIV or anti - syphilis are positive
Holter examination is abnormal and clinical significant
Subjects are not eligible for the study judged by investigators