CClinicalTrials.gg
Sign In
CompletedNCT04341090Updated Oct 22, 2021

A Food Effect Study of Apatinib Mesylate in Healthy Subjects

A Phase 1 interventional study of Apatinib Mesylate in Healthy Subjects, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Subjects
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Arm 1

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after low-fat meal, the third dose will be after high-fat meal

    Drug: Apatinib Mesylate

  • Experimental
    Arm 2

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after fasted, the third dose will be after low-fat meal

    Drug: Apatinib Mesylate

  • Experimental
    Arm 3

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after high-fat meal, the third dose will be after fasted

    Drug: Apatinib Mesylate

  • Experimental
    Arm 4

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after fasted, the second dose will be after high-fat meal, the third dose will be after low-fat meal

    Drug: Apatinib Mesylate

  • Experimental
    Arm 5

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after low-fat meal, the second dose will be after fasted, the third dose will be after high-fat meal

    Drug: Apatinib Mesylate

  • Experimental
    Arm 6

    Drug:apatinib mesylate tablet , 250 mg, 3 discrete single doses separated by 4-days: the first dose will be after high-fat meal, the second dose will be after low-fat meal, the third dose will be after fasted

    Drug: Apatinib Mesylate

Interventions

  • DrugApatinib Mesylate

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

06

What researchers measure

Primary outcomes

  1. Cmax

    Maximum Observed Plasma Concentration for apatinib \[ Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours \]

    Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours

  2. AUC0-t

    Area Under the Concentration-time Curve From Zero (Pre-dose) to Time of Last Quantifiable Concentration for apatinib

    Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours

  3. AUC0-inf

    Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for apatinib

    Time frame: Time Frame: Day 1: 0-72 hours; Day5: 0-72 hours;Day9:0-72hours

07

Study locations

1 site
  • Beijing Luhe Hospital, Capital Medical University
    Beijing, Beijing 101100, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04341090
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 10, 2020
Start date
May 13, 2020
Primary completion
Jul 6, 2020
Completion
Jul 6, 2020
Last update
Oct 22, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Jiangsu HengRui Medicine Co., Ltd.

Start the discussion