Health VolunteerPhase 1NCT07076459
A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects
A Phase 1 study testing HR091506 tablet in people with Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- HR091506 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 18 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 18 and 50 years, inclusive.
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
- Prior to screening, during the trial, and for 90 days after the last administration, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
- Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
Who cannot join
- Subjects with history of drug or food allergies.
- Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems.
- Use of any medication within 14 days prior to dosing.
- Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 90 days before the trial, or plan to participate in other clinical trials during the study.
- Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 90 days prior to screening.
- Subjects who take more than 5 cigarettes per day on average within 90 days prior to the study or do not agree to prohibit smoking during the study.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.
- Conditions
- Health Volunteer
- Being tested
- HR091506 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR091506 tabletDrug
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R Receives: Drug: HR091506 tablet |
| Sequence 2 | Experimental | Period 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1 Receives: Drug: HR091506 tablet |
| Sequence 3 | Experimental | Period 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2 Receives: Drug: HR091506 tablet |
| Sequence 4 | Experimental | Period 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R Receives: Drug: HR091506 tablet |
| Sequence 5 | Experimental | Period 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2 Receives: Drug: HR091506 tablet |
| Sequence 6 | Experimental | Period 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1 Receives: Drug: HR091506 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum plasma concentration. Blood samples will be collected.
Measured: From 0 hour predose up to 36 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: From 0 hour predose up to 36 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: From 0 hour predose up to 36 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Measured: From 0 hour predose up to 36 hours postdose
Secondary outcomes (1)
Incidence of treatment emergent AEs (TEAEs)
Measured: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start10 Jul 2025
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076459
- Sponsor's protocol ID
- HR091506-104
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07076459
- Acronym / sponsor ID
- HR091506-104
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R |
| Sequence 2 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1 |
| Sequence 3 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2 |
| Sequence 4 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R |
| Sequence 5 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2 |
| Sequence 6 | Experimental | Drug: HR091506 tabletPeriod 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the ages of 18 and 50 years, inclusive.
- At least 50.0 kg for male subjects, 45.0 kg for female subjects, with a Body Mass Index (BMI) between 19.0-26.0 kg/m2, inclusive (BMI = weight/height2).
- Prior to screening, during the trial, and for 90 days after the last administration, subjects (including male subjects) must not have plans to conceive and must voluntarily adopt effective contraceptive measures.
- Subjects who could understand the nature, significance, potential benefits, inconvenience, and potential risks of the study, understand the procedures and methods, be willing to complete the trial strictly following the protocol, and voluntarily sign the informed consent.
Key exclusion criteria (6 listed)
- Subjects with history of drug or food allergies.
- Subjects with a history of diseases related to the circulatory, endocrine, nervous, digestive, respiratory, hematolymphatic, immune, mental, skin, bone, muscle, urogenital, mucosal, and metabolic systems.
- Use of any medication within 14 days prior to dosing.
- Subjects who have taken any clinical investigational products or participated in the clinical research of medical devices within 90 days before the trial, or plan to participate in other clinical trials during the study.
- Subjects who have donated blood or experienced blood loss greater than 300 mL, or have received a blood transfusion or used blood products within 90 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HR091506 tabletIn each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）. | Drug | Sequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6 |
Primary outcome
Cmax: Maximum plasma concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 36 hours postdose
AUC0-t: Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: From 0 hour predose up to 36 hours postdose
AUC0-∞: Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: From 0 hour predose up to 36 hours postdose
Tmax: Observed time to reach Cmax. Blood samples will be collected.
Time frame: From 0 hour predose up to 36 hours postdose
1 secondary outcome
Incidence of treatment emergent AEs (TEAEs)
Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HR091506 tablet in people with Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax: Maximum plasma concentration. Blood samples will be collected. (time frame: From 0 hour predose up to 36 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.