CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions

NCT06758778 | Enrolling By Invitation

• 1 other identifier: BE-001-2024
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the oral bioavailability of 'CreNeuroS CNS Fish Oil Plus Softgels \[Eicosapentaenoic Acid (as Ethyl Ester) 342 mg; L-5-methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals\] (Test Product) compared with co-administration of Omega-3-acid Ethyl ester 1000 mg Capsules (Reference Product-1) and L-methylfolate Calcium 7.5 mg Capsules (Reference Product-2) in healthy human adult subjects under fasting conditions.

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

• Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate

  AUC (Area under curve)

  Pharmacokinetic plasma samples collected over 432.00 hours (Eicosapentaenoic acid) and 16 hours (L-5-methyltetrahydrofolate) period

Secondary Outcomes (1)

• Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate

  Pharmacokinetic plasma samples collected over 432.00 hours (Eicosapentaenoic acid) and 16 hours (L-5-methyltetrahydrofolate) period

Study Arms (2)

CreNeuroS CNS Fish Oil Plus Softgel

EXPERIMENTAL

CreNeuroS CNS Fish Oil Plus Softgel \[380 mg of fish oil contains Eicosapentaenoic Acid (EPA) （as EE）342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals\] Distributed by: Fidelity Biopharma Co., USA.

Dietary Supplement: CreNeuroS CNS Fish Oil Plus Softgel [380 mg of fish oil contains Eicosapentaenoic Acid (EPA) （as EE）342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals]

Reference Product

ACTIVE COMPARATOR

Reference product (R1): Vascepa® (Icosapent ethyl) 1000 mg Capsules Manufactured by：Patheon Softgels B.V. Reference product (R2): Deplin® (L-methylfolate Calcium) 7.5 mg Capsules Manufactured by：Alfasigma USA, Inc.

Dietary Supplement: Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules

Interventions

CreNeuroS CNS Fish Oil Plus Softgel [380 mg of fish oil contains Eicosapentaenoic Acid (EPA) （as EE）342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals] DIETARY_SUPPLEMENT

Test product

CreNeuroS CNS Fish Oil Plus Softgel

Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules DIETARY_SUPPLEMENT

Reference product

Reference Product

Eligibility Criteria

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

You may qualify if:

• Healthy human subjects aged between 18 and 45 years (including both).
• Subjects with a BMI between 18.50-25.00 Kg/m2 (including both) but body weight not less than 50 Kgs.
• Subjects with normal health as determined by personal medical history, Clinical examination and laboratory examinations including serological tests during the screening as per section 5.3.
• Subjects having normal 12-lead electrocardiogram (ECG).
• Subjects having normal chest X-Ray (P/A view) whose X-Ray was taken not more than 180 days prior to the check-in of Period-I.
• Subjects able to communicate effectively.
• Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
• Subject is a non-smoker or moderate smoker (not more than 10 cigarettes or beedis/day).
• Subject is a non-alcoholic or non-alcoholic abuse (Alcohol abuse will be defined as \>14 drinks per week (1 drink=360 mL beer, 150 mL wine or 45 mL hard liquor).

You may not qualify if:

• Subjects having contraindications or hypersensitivity to study drug or related group of drugs.
• An unusual or abnormal diet, for whatever reason within 48.00 hours prior to admission of each period, e.g., fasting due to religious reasons.
• History of Hypertension.
• History of dehydration from diarrhea, vomiting or any other reason within a period of 24.00 hours prior to study admission of each study period.
• Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the admission of each study period.
• Positive results for alcohol consumption during the admission of each study period.
• Intolerance to venipuncture.
• History or presence of any medical condition or disease according to the opinion of the physician.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• Difficulty with donating blood.
• Major illness during 90 days before check-in.
• Participation in a drug Research study within past 90 days of check-in.
• Donation of blood (i.e. one unit or 350 mL) in the past 90 days before check-in.
• Difficulty in swallowing solid dosage forms like tablets or capsules.
• Volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing.

Sponsors & Collaborators

• Sichuan Credit Pharmaceutical Co., Ltd.: lead
• Glogen Clinical Research Pvt. Ltd: collaborator

Study Sites (1)

GloGen Clinical Research Pvt. Ltd.

Hyderabad, Telangana, 500072, India

Location

Related Publications (1)

• Rusca A, Di Stefano AF, Doig MV, Scarsi C, Perucca E. Relative bioavailability and pharmacokinetics of two oral formulations of docosahexaenoic acid/eicosapentaenoic acid after multiple-dose administration in healthy volunteers. Eur J Clin Pharmacol. 2009 May;65(5):503-10. doi: 10.1007/s00228-008-0605-4. Epub 2009 Jan 16.

  PMID: 19148629 BACKGROUND

Related Links

• Pharmacokinetic study on the utilisation of 5-methyltetrahydrofolate and folic acid in patients with coronary artery disease

MeSH Terms

Interventions

Minerals; eicosapentaenoic acid ethyl ester; Capsules; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Inorganic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 6, 2025
• Study Start: January 3, 2025
• Primary Completion: January 3, 2025
• Study Completion: March 1, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)