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NCT Number: NCT07639905

A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets

This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets 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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
  • Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
  • Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 [BMI = weight (kg) / height2 (m2)] (including both endpoints).
  • Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.

Exclusion criteria

  • Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
  • Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
  • Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
  • Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
  • Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.
  • Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result.
  • Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result.
  • The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study.
  • Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
  • Pregnant and lactating women.
  • Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
  • Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.

Treatment and study plan

HRS-2189 Tablet

Drug

HRS-2189 tablet, oral.

Primary outcomes

  1. The maximum plasma concentration (Cmax)

    Time frame: Day1 - Day37.

  2. From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t)

    Time frame: Day1 - Day37.

  3. Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf)

    Time frame: Day1 - Day37.

Secondary outcomes

  1. Time to maximum plasma concentration (Tmax)

    Time frame: Day1 - Day37.

  2. Terminal half-life (t1/2)

    Time frame: Day1 - Day37.

  3. Apparent clearance (CL/F)

    Time frame: Day1 - Day37.

  4. Apparent volume of distribution (Vz/F)

    Time frame: Day1 - Day37.

  5. Incidence and severity of adverse events (AEs)

    Time frame: Day1 - Day37.

    Safety measure.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shandong Suncadia Medicine Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

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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