Bioavailability and Pharmacokinetics
Conditions
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.
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_SUPPLEMENTEicosapentaenoic Acid (EPA) and Calcium L-5-Methyltetrahydrofolate (L-5-MTHF)
This study to assess the pharmacokinetic profile of single ascending dose
Sponsors
Sichuan Credit Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Single Ascending Dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic analysis | Pharmacokinetic plasma samples collected over 432.00 hours for Eicosapentaenoic acid and 16 hours for L-5-methyltetrahydrofolate | Concentration of Eicosapentaenoic Acid, Calcium L-5-Methyltetrahydrofolate in plasma samples will be measured using LC-MS/MS |
Countries
India
Contacts
CONTACTHitesh Shah
Outcome results
None listed