Status:
COMPLETED
A Food Effect Study of Apatinib Mesylate in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The primary objective of the study was to assess the effect of high-fat and low-fat meal on the pharmacokinetics of apatinib mesylate in Chinese adult healthy subjects. The secondary objective of the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04341090
Start Date
May 13 2020
End Date
July 6 2020
Last Update
October 22 2021
Active Locations (1)
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1
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 101100