Pharmacokinetic Study of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-… (NCT07461649) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
India32 participantsStarted 2026-03-15
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexALL
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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.
What they're measuring
1
Pharmacokinetic analysis
Timeframe: Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate