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BioavailabilityBE-001-2024NCT06758778

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

A study testing 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] and Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules in people with Bioavailability, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Bioavailability
What is being tested?
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] and Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteIndia
Study dates
3 Jan 2025to Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • • 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.
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  • 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).
  • Additional inclusion criteria for female subjects, Female of childbearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD) or abstinence: or Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).

Who cannot join

  • • 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.
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  • 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.
  • Additional exclusion criteria for female subjects, Volunteer demonstrating a positive pregnancy test. Volunteers who are pregnant, currently breast-feeding or who are likely to become pregnant during the study.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

India1 site

  • GloGen Clinical Research Pvt. Ltd.

    Hyderabad, Telangana, 500072

Other trials in India

About this study

Official title: An Open-Label, Balanced, Randomized, Single Dose, Two-Treatment, Two-Sequence, Two-Period ,Two-Way Crossover Oral Bioavailability Study of CreNeuroSTM 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 Icosapent Ethyl 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

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.

Read the detailed description

This is an Open-Label, Balanced, Randomized, Single Dose, Two-Treatment, Two-Sequence, Two-Period ,Two-Way Crossover oral Bioavailability study of CreNeuroSTM 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.

A total number of 14 normal healthy adult human subjects will be included in the study.

A total of 35 blood samples will be collected from each subject in each study period.

There will be atleast 28 days washout period between two treatments in the study.

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
  • L-5-methyltetrahydrofolate (L-5-MTHF) in plasma
Conditions
Bioavailability
Being tested
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], Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

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

    Reference product

Study groups in NCT06758778
Study groupRoleWhat they receive
CreNeuroS CNS Fish Oil Plus SoftgelExperimentalCreNeuroS 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.
Receives: 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 ProductActive comparatorReference 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.
Receives: Dietary Supplement: Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate

    AUC (Area under curve)

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

Secondary outcomes (1)

  1. Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate

    Tmax (Time to achieve maximum plasma concentration)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start3 Jan 2025
  3. Primary completion3 Jan 2025
  4. Study completionMar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
14 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06758778
Sponsor's protocol ID
BE-001-2024
Acronym
BE-001-2024
Status last verified
Jan 2025
First submitted
23 Dec 2024
Last updated
23 Jan 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19148629

Questions about this trial

What is this clinical trial studying?

A study testing 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] and Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules in people with Bioavailability, run by Sichuan Credit Pharmaceutical Co., Ltd. at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate (time frame: Pharmacokinetic plasma samples collected over 432.00 hours (Eicosapentaenoic acid) and 16 hours (L-5-methyltetrahydrofolate) period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06758778, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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