A Trial of HRS-9813 Capsule and Tablet in Healthy Subjects

July 4, 2025 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

Evaluation of the Relative Bioavailability of HRS-9813 Capsule and Tablet in Healthy Subjects and the Effect of Food on the Pharmacokinetics of HRS-9813 Capsule

This is a phase Ⅰ study to evaluate the relative bioavailability of HRS-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of HRS-9813 capsule.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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 Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Aged 18-45 years.
  2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-26 kg/m2.
  3. Subjects not with clinically significant vital signs and laboratory tests.
  4. Take contraception measures.

Exclusion Criteria:

  1. Any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug.
  2. Severe infection, severe trauma or major surgery.
  3. Any medications in the two weeks before screening or baseline period.
  4. History of blood donation or severe blood loss.
  5. Have been vaccinated within 2 weeks before the screening or baseline period.
  6. History of smoking or excessive alcohol or drug abuse.
  7. Other situations that the researcher judges to be unsuitable.

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
Intervention / Treatment
Experimental: HRS-9813 Capsule Group
Drug: HRS-9813 Capsule
HRS-9813 capsule.
Experimental: HRS-9813 Tablet Group
Drug: HRS-9813 Tablet
HRS-9813 tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration of HRS-9813 capsule (Cmax)
Time Frame: Day 1-Day 23.
Day 1-Day 23.
Maximum observed concentration of HRS-9813 tablet (Cmax)
Time Frame: Day 1-Day 23.
Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 tablet (AUC0-inf)
Time Frame: Day 1-Day 23.
Day 1-Day 23.
Area under the concentration-time curve from time 0 to infinity of HRS-9813 capsule (AUC0-inf)
Time Frame: Day 1-Day 23.
Day 1-Day 23.

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs)
Time Frame: Day 1-Day 23.
Day 1-Day 23.
Time to Cmax of HRS-9813 capsule (Tmax).
Time Frame: Day 1-Day 23.
Day 1-Day 23.
Time to Cmax of HRS-9813 tablet (Tmax).
Time Frame: Day 1-Day 23.
Day 1-Day 23.

Collaborators and Investigators

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

Sponsor

Guangdong Hengrui Pharmaceutical 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)

May 4, 2025

Primary Completion (Actual)

June 3, 2025

Study Completion (Actual)

June 23, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 4, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRS-9813-103

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.

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