A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects
NCT ID: NCT07076459
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2025-07-10
2025-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Sequence 1
Period 1: HR091506 tablet T1 Period 2: HR091506 tablet T2 Period 3: HR091506 tablet R
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Sequence 2
Period 1: HR091506 tablet T2 Period 2: HR091506 tablet R Period 3: HR091506 tablet T1
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Sequence 3
Period 1: HR091506 tablet R Period 2: HR091506 tablet T1 Period 3: HR091506 tablet T2
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Sequence 4
Period 1: HR091506 tablet T2 Period 2: HR091506 tablet T1 Period 3: HR091506 tablet R
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Sequence 5
Period 1: HR091506 tablet T1 Period 2: HR091506 tablet R Period 3: HR091506 tablet T2
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Sequence 6
Period 1: HR091506 tablet R Period 2: HR091506 tablet T2 Period 3: HR091506 tablet T1
HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Interventions
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HR091506 tablet
In each period under fed conditions, subjects received oral administration of either HR091506 tablet（T1）, HR091506 tablet（T2）, or HR091506 tablet（R）.
Eligibility Criteria
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Inclusion Criteria
2. 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).
3. 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.
4. 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.
Exclusion Criteria
2. 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.
3. Use of any medication within 14 days prior to dosing.
4. 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.
5. 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.
6. 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.
18 Years
50 Years
ALL
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cangzhou Central Hospital
Cangzhou, Hebei, China
Countries
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Other Identifiers
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HR091506-104
Identifier Type: -
Identifier Source: org_study_id
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