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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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.
- •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).
排除标准
- •• 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 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.
结局指标
主要结局
Baseline-adjusted total eicosapentaenoic acid and baseline-adjusted L-5-methyltetrahydrofolate
时间窗: Pharmacokinetic plasma samples collected over 432.00 hours (Eicosapentaenoic acid) and 16 hours (L-5-methyltetrahydrofolate) period
AUC (Area under curve)
次要结局
- 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)