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
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF): This study to assess the pharmacokinetic profile of single ascending dose
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Pharmacokinetic analysis — 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
Trial sites (1)
Facility
City
Region
Status
Spinos Lifescience and Research Private Limited
Coimbatore
Tamil Nadu
More Sichuan Credit Pharmaceutical Co., Ltd. trials in India
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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