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Completed

NCT Number: NCT07040787

Investigation of Drug-drug Interaction of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects

The study is being conducted to compare the drug-drug interaction of HRS-5965 with clopidogrel and clarithromycin in healthy subjects.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330019, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (ICF) in writing.
  • Aged 18-45 years old on the date of signing the ICF (including the threshold), both male and female.
  • At the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (BMI): 19~26 kg/m2 (including the threshold).
  • During the screening period, human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV-Ab) were all negative.
  • Female subjects with reproductive capacity or male subjects whose partners are female subjects with reproductive capacity need to have no plans for fertility or sperm/egg donation within 3 months +1 week for male subjects and 6 months +1 week for female subjects from the date of signing the informed consent form until the last medication use, and voluntarily take efficient contraceptive measures (including partners).

Exclusion criteria

  • Allergic to two or more allergens, or in the judgment of the investigator, may be allergic to the study drug or its components.
  • Disease or medical condition that, in the judgment of the investigator, may interfere with the absorption, distribution, metabolism, and excretion of the drug or that may reduce compliance.
  • Patients with a previous history of coronary artery disease, severe cardiac insufficiency, conduction disorders or clinically significant bradycardia.
  • Patients with a history of electrolyte disorders (such as hypomagnesemia).
  • Patients with a history of congenital or acquired QT interval prolongation or ventricular arrhythmia.
  • Those with a history of meningococcal infection and streptococcus pneumoniae infection.
  • Those with a history of neuromuscular diseases (such as myotonic dystrophy, poliomyelitis, myasthenia gravis, botulism poisoning) and poliomyelitis.
  • Subjects who have had or are currently suffering from active pathological bleeding.
  • Subjects with a previous history of recurrent oral ulcers.

Treatment and study plan

HRS-5965 Capsules

Drug

Oral HRS-5965 capsules.

clopidogrel

Drug

Oral clopidogrel.

Clarithromycin

Drug

Oral clarithromycin.

Primary outcomes

  1. The maximum plasma concentration (Cmax)

    Time frame: Day 1 to day 12.

  2. Area under the concentration curve from time 0 to the last quantifiable concentration (AUClast)

    Time frame: Day 1 to day 12.

Secondary outcomes

  1. Time to maximum plasma concentration

    Time frame: Day 1 to day 12.

  2. Terminal half-life (t1/2)

    Time frame: Day 1 to day 12.

  3. Incidence and severity of adverse events (AEs)

    Time frame: Day 1 up to day 19.

Sponsors and collaborators

Lead sponsor

Chengdu Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Single-arm, Fixed-sequence Drug-drug Interaction Study of HRS-5965 With Clopidogrel and Clarithromycin in Healthy Subjects

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 27, 2025
Registry last updated
Aug 20, 2025

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.

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