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CompletedNCT05440006Updated Sep 8, 2022

A Study of Food Effect on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

A Phase 1 interventional study of Fuzuloparib in Solid Tumor, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-08.

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

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of Fuzuloparib Capsules in healthy subject.

02

Conditions studied

  • Solid Tumor
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 and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy male and female subjects over 18 years;
  2. Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) of 19.0 to 26.0 kg /m2 (inclusive);
  3. Participants should have no fertility plan from signing the informed consent until 6 months after the last dose, and take effective contraceptive measures.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with evidence of disease or major surgery;
  2. History of drug allergy;
  3. Treatment with other investigational drug within 3 months, use of any prescription drugs, Chinese herbal supplements within 4 weeks, and/or need to use any over-the-counter (OTC), food supplements within 2 weeks before the first dose or during the trial;
  4. Subjects refuse to stop drinking xanthine-rich beverages or foods at 48 hours before the first dose until the end of the study, and subjects refuse to stop any beverage or food containing grapefruit 7 days before the first dose;
  5. Those who have heavy smokers, alcoholics or drug abuse
  6. Lactating female subjects or fertile female subjects
  7. Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.
05

Study design

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

Study arms

  • Experimental
    Fed+ Fasted

    The first cycle with high-fat meal, the second cycle under fasting.

    Drug: Fuzuloparib

  • Experimental
    Fasted + Fed

    The first cycle under fasting, the second cycle with high-fat meal.

    Drug: Fuzuloparib

Interventions

  • DrugFuzuloparib

    Fuzuloparib Capsules; 150mg; single dose per cycle.

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax)

    Time frame: day 1 to day 10

  2. Area under the plasma concentration versus time curve from time 0 to last time of measurable concentration (AUC0-t)

    Time frame: day 1 to day 10

  3. Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-∞ )

    Time frame: day 1 to day 10

Secondary outcomes

  1. The incidence and severity of adverse events/serious adverse events

    Time frame: from ICF signing date to approximate day 23

07

Study locations

1 site
  • Wannan Medical College Yijishan Hospital
    Wuhu, Anhui 241000, 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 Sep 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05440006
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jun 30, 2022
Start date
Jul 3, 2022
Primary completion
Jul 20, 2022
Completion
Jul 20, 2022
Last update
Sep 8, 2022

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 Sep 2022. You cannot join it, but the record below documents what was studied.

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