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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pharmacokinetic analysis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Test Product
CreNeuroS® CNS Fish Oil Plus Softgels [Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)] etc.
干预措施: Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) (Dietary Supplement)
结局指标
主要结局
Pharmacokinetic analysis
时间窗: Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate
Concentration of Eicosapentaenoic Acid, Calcium L-5-Methyltetrahydrofolate in plasma samples will be measured using LC-MS/MS
次要结局
未报告次要终点