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Completed

NCT Number: NCT07076459

A Comparative Pharmacokinetic Study of Single-Dose Administration of HR091506 Tablets From Different Batches in Healthy Subjects

To evaluate the pharmacokinetic characteristics of HR091506 tablets in different batches in healthy subjects after single administration.

Completed

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cangzhou Central Hospital

Cangzhou, Hebei, 061000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HR091506 tablet

Drug

In each period under fed conditions, subjects received oral administration of either HR091506 tablet(T1), HR091506 tablet(T2), or HR091506 tablet(R).

Primary outcomes

  1. Cmax: Maximum plasma concentration. Blood samples will be collected.

    Time frame: From 0 hour predose up to 36 hours postdose

  2. 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

  3. 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

  4. Tmax: Observed time to reach Cmax. Blood samples will be collected.

    Time frame: From 0 hour predose up to 36 hours postdose

Secondary outcomes

  1. Incidence of treatment emergent AEs (TEAEs)

    Time frame: From Signing of Informed Consent Form (ICF) up to Safety Follow Up (Up to Day 24)

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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