Bioequivalence Test of Eltrombopag Olamine Tablets in Humans Under Fasting State

Inclusion criteria

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Able to complete the study according to the requirements of the trial protocol;
• The participants (including their partners) are willing to voluntarily use effective contraceptive methods within 6 months from screening until the last dose of study drug, as detailed in the Appendix;
• Male and female subjects aged 18-55 years old (including 18 and 55 years old);
• he body weight of male subjects should not be less than 50 kg and the body weight of female subjects should not be less than 45 kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI in the range of 18-28 kg/m2 (including the cut-off value);
• Health condition: History of no heart, liver, kidney, digestive tract, nervous system, mental disorders, metabolic disorders, etc；
• The physical examination was normal or abnormal without clinical significance.

Exclusion criteria

• Smoking more than 5 cigarettes per day in the 3 months before the study;
• Allergic constitution (multi-drug and food allergy);
• A history of drug and/or alcohol abuse (drinking 14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 ml wine);
• Donation or massive blood loss (> 400 mL) within 3 months before screening;
• Taking any drugs that alter liver enzyme activity 28 days before screening;
• Have taken any prescription medication, over-the-counter medication, any vitamin product or herbal medicine within 14 days before screening;
• Those who had taken special diet (including dragon fruit, mango, grapefruit, etc.) or had strenuous exercise within 2 weeks before screening, or had other factors affecting drug absorption, distribution, metabolism, and excretion;
• Combined with the following inhibitors or inducers of CYP3A4, P-gp, or Bcrp, such as itraconazole, ketoconazole, or dronedarone;
• A recent major change in diet or exercise habits;
• Have taken a study drug or participated in a clinical trial of the drug within three months before taking the study drug;
• A history of dysphagia or any gastrointestinal disorder affecting drug absorption or a history of cholecystectomy or biliary tract disease;
• Have any condition that increases the risk of bleeding, such as hemorrhoids, acute gastritis or gastric and duodenal ulcers;
• ECG abnormalities have clinical significance;
• The female subjects were lactating or seropositive for pregnancy during the screening or test period;
• Clinically significant abnormalities on clinical examination or other clinical findings (including but not limited to gastrointestinal, renal, hepatic, neurological, hematologic, endocrine, oncologic, pulmonary, immune, psychiatric, or cardio-cerebrovascular diseases);
• Viral hepatitis (including hepatitis B and C), AIDS antibody, treponema pallidum antibody positive;
• From the screening stage to the onset of acute illness before study medication;
• Consumption of chocolate, any caffeinated or xanthine-rich food or beverage 48 hours before taking the study drug;
• Have taken any alcohol-based product within 24 hours before taking the study medication;
• Individuals who test positive for alcohol and drugs or have a history of drug abuse within the past five years or have used drugs in the three months prior to the experiment;
• Difficulty in blood collection or inability to tolerate venipuncture blood collection;
• The subject is unable or unable to comply with ward management regulations;
• The subject is unable to complete the experiment due to personal reasons;
• Other researchers determine that it is not suitable for selection in this project.