Bioavailability
Conditions
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.
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
Interventions
DIETARY_SUPPLEMENTCreNeuroS 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]
Test product
DIETARY_SUPPLEMENTVascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules
Reference product
Sponsors
Glogen Clinical Research Pvt. Ltd
Sichuan Credit Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* • 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). * 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).
Exclusion criteria
* • 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. * Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | AUC (Area under curve) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Tmax (Time to achieve maximum plasma concentration) |
Countries
India
Outcome results
None listed