Skip to main content
OpenTrials
Completed

NCT Number: NCT05440006

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female subjects over 18 years;
  • 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);
  • 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

  • Subjects with evidence of disease or major surgery;
  • History of drug allergy;
  • 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;
  • 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;
  • Those who have heavy smokers, alcoholics or drug abuse
  • Lactating female subjects or fertile female subjects
  • Those with clinically significant abnormality of physical examination, vital signs and laboratory test during the screening period.

Treatment and study plan

Fuzuloparib

Drug

Fuzuloparib Capsules; 150mg; single dose per cycle.

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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

Randomized, Open, Two Cycle, Two Sequence, Cross Reference Designed Study on the Effect of Food on the Pharmacokinetics of Fuzuloparib Capsules in Chinese Healthy Adult Subjects

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2022
Registry last updated
Sep 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.