A Food Effect Study of Apatinib Mesylate in Healthy Subjects

A Randomized, Open-label, Single Dose, Three-period, Six-sequences, Crossover Study of High-fat and Low-fat Meal Effect on the Pharmacokinetics of Apatinib Mesylate in Chinese Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04341090

Enrollment

Registered

2020-04-10

Start date

2020-05-13

Completion date

2020-07-06

Last updated

2021-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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 study was to assess the safety of apatinib mesylate administered in adult healthy subjects.

Interventions

DRUGApatinib Mesylate

Single dose of apatinib mesylate after high-fat meal, low fat meal and fast

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

1. 18-45 years of age, male or female, each gender should be more than 1/4 of the whole sample size. 2. The weight of male subject ≥50kg, weight of female subject ≥45kg, 19≤BMI≤28kg/m2 3. In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG; 4. 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; 5. Able to comprehend and willing to sign an informed consent form (ICF)

Exclusion criteria

1. History of drug allergy, or allergic to apatinib or ingredients; 2. Drinking 14 units of alcohol per week within 6 months prior dosing(1 unit = 360 mL of beer, or 150mL of wine) ; 3. 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; 4. Take any clinical trial drugs within 3 months prior dosing; 5. 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. 6. Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection; 7. 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; 8. Anyone who refuse to stop ingesting grapefruit or grapefruit-containing products from 7 days before dosing to the end of the study; 9. The investigator believes that the subjects are not eligible to participate in this trial.

Design outcomes

Primary

Measure	Time frame	Description
Cmax	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours	Maximum Observed Plasma Concentration for apatinib \[ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours \]
AUC0-t	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours	Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib
AUC0-inf	Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours	Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026