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

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

Inclusion criteria

• 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).

Exclusion criteria

• 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.