A Clinical Study to Evaluate the Effect of Different Dosing Conditions on the Pharmacokinetics of HRS9531 Tablets in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-55
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

The study is being conducted to evaluate the effects of different dosage regimen on the pharmacokinetics of HRS9531 tablets in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Ability to understand the trial procedures, be able and willing to provide a written informed consent.

Male subject aged 18-55 years (both inclusive) at the time of signing informed consent.

Body weight ≥ 50.0 kg, body mass index (BMI) of 23.0-35.0 kg/m² (both inclusive) at screening.

Weight change does not exceed 5 kg within 3 months before screening.

Disqualifiers

Known or suspected hypersensitivity to trial product(s) or related products.

With previous major organ diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, are judged by researchers to be unsuitable for the study.

Abnormal and clinically significant blood pressure at screening.

History of significant gastrointestinal diseases or related symptoms (e.g., nausea, vomiting, heartburn, or diarrhea), conditions affecting gastric emptying (e.g., pyloric stenosis), or previous gastrointestinal surgery (excluding polypectomy and appendectomy), or acute diarrhea or constipation within 7 days before randomization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS9531 tablets

    Drug

    HRS9531 tablets.

Treatment groups

100 Participants
are divided into 5 treatment groups
Group A: Treatment group AExperimental treatment 1 intervention
Group B: Treatment group BExperimental treatment 1 intervention
Group C: Treatment group CExperimental treatment 1 intervention
Group D: Treatment group DExperimental treatment 1 intervention
Group E: Treatment group EExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

AUCtau

Area under the HRS9531 tablets concentration curve from time 0-24 hours after the 10th dosing

Time frame
0-24 hours after the 10th dosing.

Secondary outcomes

1

Tmax

Time to maximum plasma concentration

Time frame
First dose at day 1 and post-dose at day 10.
2

Cmax

The maximum plasma concentration

Time frame
First dose at day 1 and post-dose at day 10.
3

t1/2

Terminal half-life

Time frame
First dose at day 1 and post-dose at day 10.
4

Incidence and severity of adverse events

Time frame
Screening period up to Day 45.

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: