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

NCT07461649 | Not Yet Recruiting

• 1 other identifier: SLS-BE-0145-25-CREN
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bioavailability and Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic analysis

  Concentration of Eicosapentaenoic Acid, Calcium L-5-Methyltetrahydrofolate in plasma samples will be measured using LC-MS/MS

  Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate

Study Arms (1)

Test Product

EXPERIMENTAL

CreNeuroS® CNS Fish Oil Plus Softgels \[Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)\] etc.

Dietary Supplement: Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)

Interventions

Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF) DIETARY_SUPPLEMENT

This study to assess the pharmacokinetic profile of single ascending dose

Test Product

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Credit Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Spinos Lifescience and Research Private Limited

Coimbatore, Tamil Nadu, 641029, India

Location

MeSH Terms

Interventions

Eicosapentaenoic Acid; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Central Study Contacts

Hitesh Shah

CONTACT

+919821218347; hitesh@creditpharma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Ascending Dose study

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 10, 2026
• Study Start: March 15, 2026
• Primary Completion: April 23, 2026
• Study Completion: May 10, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

IN (1)