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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
Sponsor: Sichuan Credit Pharmaceutical Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
32
Start Date
2026-03-15
Completion Date
2026-05-10
Last Updated
2026-03-16
Healthy Volunteers
Yes
Conditions
Interventions
Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
This study to assess the pharmacokinetic profile of single ascending dose
Locations (1)
Spinos Lifescience and Research Private Limited
Coimbatore, Tamil Nadu, India