A Clinical Study Comparing the Bioavailability of HRS-2189 Tablets

Официальное название

A Single-center, Single-dose, Randomized, Open-label, Two-period, Crossover Clinical Study on the Bioavailability and Safety of the New and Old Formulations HRS-2189 Tablets in Healthy Subjects

Обзор

This study is a single-center, single-dose, randomized, open-label, two-period, crossover phase I clinical trial, comparing the bioavailability and safety of the new and old processes of HRS-2189 tablets in healthy subjects.

Вмешательства

• Препарат HRS-2189 Tablet
  HRS-2189 tablet, oral.

Первичные конечные точки

• The maximum plasma concentration (Cmax) [Срок оценки: Day1 - Day37.]
• From time 0 to the area under the blood drug concentration-time curve corresponding to the last quantifiable concentration (AUC0-t) [Срок оценки: Day1 - Day37.]
• Area under the concentration curve from time 0 to extrapolated infinite time (AUCinf) [Срок оценки: Day1 - Day37.]

Вторичные конечные точки (5)

• Time to maximum plasma concentration (Tmax) [Срок оценки: Day1 - Day37.]
• Terminal half-life (t1/2) [Срок оценки: Day1 - Day37.]
• Apparent clearance (CL/F) [Срок оценки: Day1 - Day37.]
• Apparent volume of distribution (Vz/F) [Срок оценки: Day1 - Day37.]
• Incidence and severity of adverse events (AEs) [Срок оценки: Day1 - Day37.]

Критерии участия

Критерии включения

• Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be able to complete the research in accordance with the trial protocol requirements.
• Participants signed the informed consent form. Their age on the day of the event was between 18 and 45 years old (inclusive of both ends).
• Female weight ≥ 45 kg, male weight ≥ 50 kg, and body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 \[BMI = weight (kg) / height2 (m2)\] (including both endpoints).
• Female participants with reproductive capacity must agree to practice contraception and avoid egg donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug. Blood serum pregnancy tests must be negative before and during the trial, and they must not be in the lactation period. Male participants whose partners have reproductive capacity must agree to practice contraception and avoid sperm donation from the moment they sign the informed consent form until 3 months after the last administration of the investigational drug.

Критерии исключения

• Those who have had or currently have any clinical history of serious diseases in the circulatory system, endocrine system, nervous system, digestive system, respiratory system, urogenital system, hematology, immunology, psychiatry, and metabolism, or any chronic diseases or other diseases that may interfere with the test results.
• Those who have undergone major surgical procedures within one year prior to signing the informed consent form, or who have undergone any surgery within one month prior to signing the informed consent form, or who plan to undergo surgery during the trial period.
• Has a history of drug allergy, or is known to be allergic to the study drug/related drugs or excipients.
• Those who have a history of drug use or substance abuse, or who have a positive result in drug screening tests.
• Those who participated in other clinical trials and took the study drug within 3 months prior to the first administration of the drug.
• Those who smoked at least 5 cigarettes per day for the three months prior to the trial, or those who were unable to stop using any tobacco products during the trial, or those with a positive urine nicotine screening result.
• Those who frequently consumed alcohol within the six months prior to the trial, namely those who drank ≥ 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of 40% alcohol spirits, or 150 mL of wine), or those who were unable to give up drinking during the trial, or those with a positive blood alcohol test result.
• The results of physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation function, 12-lead electrocardiogram, imaging and ultrasound tests during the screening period were abnormal and had clinical significance. Based on the judgment of the researchers, they were not suitable to participate in this study.
• Those who are positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, and HIV antibody.
• Pregnant and lactating women.
• Those with a history of fainting during blood collection or blood transfusion, or who have difficulty in blood collection or cannot tolerate venipuncture for blood collection.
• Due to other reasons, after the researchers' evaluation, participants who were deemed unsuitable to participate in this study were excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07639905 · HRS-2189-102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗