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Набор скоро начнётся NCT07461649

Pharmacokinetic Study of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) After Administration of CreNeuroS® CNS Fish Oil Plus Softgels in Healthy Subjects Under Fasting Conditions

Без фазы С лечением Bioavailability and Pharmacokinetics

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF).
Кому может быть актуально
Состояния в реестре: Bioavailability and Pharmacokinetics. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
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Официальное название

An Open-Label, Balanced, Randomized, Single Ascending Dose Study, To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate (L-S-MTHF) Following Oral Administration Of Different Dose Levels of CreNeuroS® CNS Fish Oil Plus Softgels Supplied By Sichuan Credit Pharmaceutical Co., Ltd, China in Healthy Subjects Under Fasting Conditions

Обзор

Demographic data, medical and medication history, physical examination, 12-lead ECG, haematology, biochemistry, serology, urine routine analysis, additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and a chest X-ray within 06 months prior to check-in. In study period, each group subjects will be housed in the clinical facility for at least -60.00 hours pre-dose to 72.00 hours post-dose.

Подробное описание

This is an An Open-Label, Balanced, Randomized, Single Ascending Dose Study, To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) Following Oral Administration Of Different Dose Levels of CreNeuroS® CNS Fish Oil Plus Softgels Supplied By Sichuan Credit Pharmaceutical Co., Ltd, China in Healthy Subjects Under Fasting Conditions.

A total number of 32 normal healthy adult human subjects will be included in the study.

A total of 36 blood samples will be collected from each subject. The following analytes will be determined in plasma using a validated LC-MS/MS (Liquid chromatography tandem mass spectrometry) method.

* Total Eicosapentaenoic Acid (EPA) in plasma * Free Eicosapentaenoic Acid (EPA) in plasma * L-5-methyltetrahydrofolate (L-5-MTHF) in plasma

Вмешательства

  • Пищевая добавка Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
    This study to assess the pharmacokinetic profile of single ascending dose

Первичные конечные точки

  • Pharmacokinetic analysis [Срок оценки: Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate]

Критерии участия

Критерии включения

  • Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in.
  • Subjects whose screening laboratory values are within normal limits are considered by the physician or principal/clinical investigator to be of no clinical significance.
  • Healthy as documented by the medical history, physical examination and vital examinations.
  • Generally healthy, as documented by a 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments.
  • Willing to consume Ovo lacto-vegetarian diet.
  • Willing to comply with all requirements of this study protocol as well as instructions from the study personnel.
  • Generally healthy, as documented by gynaecological examination and breast examination (for female subjects).

Критерии исключения

  • Evidence of allergy or known hypersensitivity to Eicosapentaenoic Acid (EPA) and Calcium L-S-Methyltetrahydrofolate (L-S-MTHF) or its inactive ingredients.
  • Evidence of allergy to fish or shellfish.
  • Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, and pre-existing gall bladder disease.
  • Any major illness in the last three months or any significant ongoing chronic medical illness.
  • Renal or liver impairment.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Индия · 1 центр
  • Spinos Lifescience and Research Private Limited — Coimbatore

Идентификаторы

NCT: NCT07461649 · SLS-BE-0145-25-CREN

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗