A Bioequivalence Study of Two Formulations of HRS-1893 Tablets in Healthy Participants

August 14, 2026 updated by: Shandong Suncadia Medicine Co., Ltd.
This study will investigate the bioequivalence between two formulations of HRS-1893 tablets. Safety and tolerability will also be assessed.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Subjects aged 18 to 55 years (inclusive), regardless of gender;
  2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥ 50.0 kg and < 90.0 kg for men, and ≥ 45.0 kg and < 90.0 kg for women;
  3. No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment;
  4. No clinically significant abnormalities on the 12-lead ECG;
  5. The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.

Exclusion Criteria:

  1. Subjects with suspected hypersensitivity to the investigational drug or any excipient;
  2. The subject has a history of syncope;
  3. Exclusion due to blood pressure: Systolic Blood Pressure (SBP) >140 mmHg or <90 mmHg; OR Diastolic Blood Pressure (DBP) >90 mmHg or <60 mmHg, as determined by the investigator to be clinically significant;
  4. History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption;
  5. A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag);
  6. Subjects who meet any of the following criteria will be excluded: a. Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening; b. Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits); c. Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration; d. Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse;
  7. History of substance abuse;
  8. Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded;
  9. Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HRS-1893 test formulation group
Drug: Test formulation of HRS-1893 tablet
Test formulation of HRS-1893 tablet, oral.
Experimental: HRS-1893 reference formulation group
Drug: Reference formulation of HRS-1893 tablet
Reference formulation of HRS-1893 tablet, oral.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak concentration (Cmax).
Time Frame: From Day 1 to Day 17.
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Area under the plasma concentration - time curve from Time 0 to the last quantifiable time point (AUC0-t).
Time Frame: From Day 1 to Day 17.
Primary Pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Area under the plasma concentration - time curve from Time 0 to infinity (AUC0-∞).
Time Frame: From Day 1 to Day 17.
Primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to peak concentration (Tmax).
Time Frame: From Day 1 to Day 17.
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Elimination half-life (t1/2).
Time Frame: From Day 1 to Day 17.
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Apparent clearance (CL/F).
Time Frame: From Day 1 to Day 17.
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Apparent volume of distribution (Vz/F).
Time Frame: From Day 1 to Day 17.
Other primary pharmacokinetic (PK) parameters of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 17.
Incidence and severity of any adverse events (AEs).
Time Frame: From Day 1 to Day 21 ± 2.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 21 ± 2.
12-Lead Electrocardiogram (ECG) QT Interval.
Time Frame: From Day 1 to Day 21 ± 2.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 21 ± 2.
Transthoracic echocardiogram (TTE) results.
Time Frame: From Day 1 to Day 21 ± 2.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 21 ± 2.
Vital signs results - blood pressure.
Time Frame: From Day 1 to Day 21 ± 2.
Safety and tolerability of different HRS-1893 formulations in healthy subjects.
From Day 1 to Day 21 ± 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-1893-108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings