A Study to Evaluate the Pharmacokinetics and the Safety After Administration of BR1015-A and Co-administration of BR1015-3 and BR1015-2 Under Fasting Conditions

Официальное название

A Randomized, Open-label, Fasting, Oral Administration, Single Dose, 2-sequence, 4-period, Crossover Study to Evaluate the Pharmacokinetics and Safety After Administration of "BR1015-A" and Co-administration of "BR1015-3" and "BR1015-2" in Healthy Adult Volunteers

Обзор

The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions

Вмешательства

• Препарат BR1015-A
  One tablet administered alone
• Препарат BR1015-3
  One tablet administered alone
• Препарат BR1015-2
  One tablet administered alone

Первичные конечные точки

• AUCt of Fimasartan [Срок оценки: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).]
• AUCt of Indapamide [Срок оценки: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).]
• Cmax of Fimasartan [Срок оценки: From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4).]
• Cmax of Indapamide [Срок оценки: From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2).]

Критерии участия

Критерии включения

• Subjects with a body mass index (BMI) of more than 18.0 kg/m² and less than 30.0 kg/m² at the screening visit.
• Subjects who provide written informed consent voluntarily after receiving and understanding sufficient explanation regarding the purpose and procedures of the clinical trial, the characteristics of the investigational product, and the expected adverse events.
• Subjects who agree to use a highly effective method of contraception, excluding hormonal contraceptives, from the time of signing the written informed consent form until 14 days after the last administration of the investigational product, and who agree not to donate sperm or ova during this period. This requirement applies to the subject and, as applicable, to their spouse or sexual partner in order to prevent pregnancy.

Критерии исключения

• Subjects who have taken drugs that induce or inhibit metabolizing enzymes, such as barbiturates, within 30 days prior to the first administration of the investigational product, or who have taken any prescription drugs, over-the-counter drugs (OTC), herbal medicines, or dietary supplements within 10 days prior to the first administration that may interfere with the conduct of the study (however, participation may be allowed considering the pharmacokinetics and pharmacodynamics, including potential interactions with the investigational product and the half-life of concomitant drugs).
• Subjects with a medical history of gastrointestinal resection or gastrointestinal diseases that may affect the absorption of drugs (except for simple appendectomy or hernia surgery).
• Subjects who have participated in other clinical trials (including bioequivalence studies) and received investigational products within 6 months prior to the first administration of this study. For this criterion, the 6-month period is counted from the last administration date of the investigational product in the previous study.
• Subjects who are unable to discontinue consumption of foods that may affect the absorption, distribution, metabolism, or excretion of the investigational product (e.g., raw grapefruit, grapefruit juice, or foods containing grapefruit) from 48 hours prior to the first administration of the investigational product until the collection of the last pharmacokinetic blood sample.
• Subjects who, for reasons other than those specified in the inclusion and exclusion criteria above, are judged by the principal investigator (or a sub-investigator delegated by the principal investigator) to be unsuitable for participation in the clinical trial.
• Female subjects who are pregnant, suspected of being pregnant, or currently lactating.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07421401 · BR-FIC-CT-109

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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