Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets

Официальное название

Bioequivalence Study of Sacubitril Alisartan Amlodipine Tablets Versus Sacubitril Alisartan Calcium Tablets Combined With Amlodipine Besylate Tablets

Обзор

This study aims to evaluate the bioequivalence and safety of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult study participants.

Подробное описание

This study is a single-center, randomized, open-label, single oral dose, two-formulation, two-sequence, four-period, fully replicated crossover bioequivalence study designed to compare the bioequivalence of single oral administration of Sacubitril/Valsartan/Amlodipine Tablets (240mg/5mg) versus Sacubitril/Valsartan Calcium Tablets (240mg) combined with Amlodipine Besylate Tablets (5mg) in healthy adult participants.

Вмешательства

• Препарат Sequence A T-R-T-R
  The medication sequence for sequence A is as follows: in the first and third cycles, the test formulation (T: Sacubitril Alesartan Amlodipine Tablets) is taken; in the second and fourth cycles, the reference formulation (R: Sacubitril Alesartan Calcium Tablets + Benazepril Amlodipine Tablets) is taken.The administration date should be at least 14 days apart each time.
• Препарат Sequence B R-T-R-T
  The administration sequence for sequence B is as follows: in the first and third cycles, the reference formulation (R: sacubitril amlasiatin calcium tablet + benazepril hydrochloride tablet) is administered; in the second and fourth cycles, the test formulation (T: sacubitril amlasiatin and hydrochloride tablet) is administered; each administration date is at least 14 days apart.

Первичные конечные точки

• Cmax of EXP3174、Sacubitril、LBQ657、Amlodipine [Срок оценки: through study completion，an average of 47days]
• AUC0-t of EXP3174、Sacubitril、LBQ657 [Срок оценки: through study completion，an average of 47days]
• AUC0-∞of EXP3174、Sacubitril、LBQ657 [Срок оценки: through study completion，an average of 47days]
• AUC0-72h of Amlodipine [Срок оценки: From 0 o'clock to 72 hours]

Критерии участия

Критерии включения

• Study participants aged 18 to 60 years (inclusive of 18 and 60 years), both male and female
• Body weight not less than 50 kg. Body Mass Index (BMI) = weight (kg) / height\^2 (m\^2). BMI must be within the range of 19 to 26 kg/m\^2 (inclusive of the limit values)
• The study participant is able to communicate well with the research staff, fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial, and sign a written informed consent form
• The study participant or their partner has no plans for pregnancy, sperm donation, or egg donation during the study period and for 3 months after drug administration, and must agree to use at least one acceptable effective contraceptive method
• During the screening period: 110 mmHg ≤ seated systolic blood pressure (SBP) < 140 mmHg, 65 mmHg ≤ seated diastolic blood pressure (DBP) < 90 mmHg, and no orthostatic hypotension.

Критерии исключения

• Those who smoked more than 5 cigarettes per day on average in the 3 months prior to the trial and are unable to quit smoking during the trial period.
• Pregnant or breastfeeding women, or female study participants of childbearing potential with a positive blood pregnancy screening.
• Known allergic reaction to angiotensin II receptor antagonists (such as sacubitril/valsartan sodium, alisartan ester, losartan, valsartan) and calcium channel blockers (such as nifedipine, amlodipine), or their excipients; or allergic constitution (multiple drug and food allergies).
• Alcoholics or those who frequently consumed alcohol within the 3 months prior to screening, i.e., consuming more than 14 standard alcohol units per week (1 unit alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine), or those with a positive alcohol breath test, or those unable to stop using any alcohol-containing products during the trial period.
• Those who donated blood or experienced significant blood loss (>400 mL), used blood products, or received a blood transfusion within the three months prior to screening.
• Those who have undergone surgery within 3 months prior to screening or plan to undergo surgery during the study period, or subjects with a history of surgery affecting drug absorption, distribution, metabolism, or excretion.
• Those who have been vaccinated within 3 months prior to screening.
• History of hypotension, syncope, needle fainting, swallowing difficulties, any gastrointestinal disease affecting drug absorption, or any history of conditions increasing hemorrhagic risk, such as acute gastritis or gastroduodenal ulcers.
• Use of any drug that alters hepatic enzyme (CYP3A4) activity or inhibitors of transporters (OAT1/3, OATP1B1/3) within 28 days prior to screening.
• Use of any prescription drugs, over-the-counter medications, vitamin products, or herbal remedies within 14 days prior to screening.
• Participation in any drug clinical trial and administration of any other investigational drug, or use of investigational products, within 3 months prior to taking the study drug.
• Clinically significant abnormalities in vital signs, physical examination, 12-lead electrocardiogram (ECG), or laboratory tests (including complete blood count, urinalysis, blood biochemistry, coagulation profile, and four infectious disease markers) at screening.
• Any other disease or medical history considered by the investigator as unsuitable for participation in this study, such as disorders of the central nervous, cardiovascular, digestive, respiratory, urinary, hematopoietic, immune systems, psychiatric conditions, or metabolic abnormalities.
• Consumption of chocolate, any caffeine-containing, or xanthine-rich foods or beverages within 48 hours prior to taking the study drug.
• History of drug abuse or substance abuse, or a positive urine drug screen at screening.
• Those with special dietary habits who cannot comply with the unified dietary requirements, or those with lactose intolerance (e.g., history of diarrhea after drinking milk).
• Any other reason considered by the investigator as unsuitable for enrollment.

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 First Affiliated Hospital of Anhui Medical University — Хэфэй

Идентификаторы

NCT: NCT07486453 · SAL0130A102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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