A Food Effect Study of Apatinib Mesylate in Healthy Subjects

Inclusion criteria

• 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size.
• The weight of male subject ≥50kg, weight of female subject ≥45kg, 19≤BMI≤28kg/m2
• In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG;
• Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
• Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion criteria

• History of drug allergy, or allergic to apatinib or ingredients;
• Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ;
• Take any prescription or traditional Chinese medicines within four weeks prior dosing; take any over-the-counter medication, vitamin products within two weeks before dosing;
• Take any clinical trial drugs within 3 months prior dosing;
• Participate in blood donation within 3 months before screening and donate blood volume ≥400mL or blood loss ≥400mL, or receive blood transfusion; or donate blood volume≥200mL or blood loss ≥200mL within 1 month prior dosing.
• Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
• Anyone who refuse to stop ingest foods or drinks containing caffeine, xanthine or alcohol from 48 hours before dosing to the end of the study;
• Anyone who refuse to stop ingesting grapefruit or grapefruit-containing products from 7 days before dosing to the end of the study;
• The investigator believes that the subjects are not eligible to participate in this trial.