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Not yet recruiting NCT07461649

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

No phase Interventional Bioavailability and Pharmacokinetics

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF).
Who it may be relevant to
Registry conditions: Bioavailability and Pharmacokinetics. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

This is an An Open-Label, Balanced, Randomized, Single Ascending Dose Study, To Evaluate The Pharmacokinetic Dose Linearity of Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-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.

A total number of 32 normal healthy adult human subjects will be included in the study.

A total of 36 blood samples will be collected from each subject. The following analytes will be determined in plasma using a validated LC-MS/MS (Liquid chromatography tandem mass spectrometry) method.

* Total Eicosapentaenoic Acid (EPA) in plasma * Free Eicosapentaenoic Acid (EPA) in plasma * L-5-methyltetrahydrofolate (L-5-MTHF) in plasma

Interventions

  • Dietary supplement Eicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
    This study to assess the pharmacokinetic profile of single ascending dose

Primary outcome measures

  • Pharmacokinetic analysis [Time frame: Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Basic science

Study locations

India · 1 center
  • Spinos Lifescience and Research Private Limited — Coimbatore

Identifiers

NCT: NCT07461649 · SLS-BE-0145-25-CREN

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗