Single dose oral comparative bioavailability study of Omega-3 Fatty Acid in healthy adult human subjects under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To compare the bioavailability, to characterize the pharmacokinetic profile of the Test Product (T) [Vytals Fish Oil SMEDs Softgel Capsule (Each 1 g softgel contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India] with Reference Product (R) [Plain Fish Oil Softgel Capsule (Each 750mg softgel capsule contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India]
研究概览
简要总结
Single dose oral comparative bioavailability study of Omega-3 Fatty Acid in healthy adult human subjects under fasting conditions and the objective of the study is to compare the bioavailability, to characterize the pharmacokinetic profile of the Test Product (T) [Vytals Fish Oil SMEDs Softgel Capsule (Each 1 g softgel contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India] with Reference Product (R) [Plain Fish Oil Softgel Capsule (Each 750mg softgel capsule contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India].
Conducted at a single center, open label, randomized, balanced, two-treatment, two-sequence, two-period, single dose, two-way crossover study involves 20 subjects. Each participant will receive both treatments in a randomized order with a washout period of at least 7 days between doses. Subjects will be housed in the clinical facility at least 12 hours prior to dosing and after an overnight fasting of at least 10 hours dosing will be there. Subjects will continue to remain in the clinical facility for at least 24 hours after dosing in each period. Blood samples will be collected pre-dose and at multiple time points post-dose to assess pharmacokinetic parameters.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Male
入选标准
- •1.Subject’s age should be between 18 to 50 years (both inclusive).
- •Subjects who are able to read and write the vernacular language (English and Hindi) and understand the study requirements.
- •Must have provided written informed consent for participation in the study in the subject’s vernacular language (English and Hindi).
- •Minimum weight 50.0 kg.
- •BMI 18.50 to 29.50 Kg per m2 (both inclusive).
- •Healthy as determined by medical history, physical, clinical and laboratory examination performed within 28 days prior to admission for the first period of the study.
- •In the opinion of the Principal Investigator or Co Investigator or designee, be able to comply with the study procedures and protocol restrictions.
排除标准
- •Known hypersensitivity (include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria) or idiosyncratic reaction to (omega 3 fatty acid) or any substituted benzimidazole and its excipients or similar classes of drugs.
- •Any evidence of significant abnormalities upon physical or clinical examination.
- •Laboratory values, which are significantly different from pre defined reference ranges and judged clinically significant.
- •Consumption of grapefruit juice grapefruit at least 48 hours prior to admission in all period of the study.
- •Clinical symptoms of Cyanocobalamin (Vitamin B 12) Deficiency
- •Any clinically significant abnormality in Chest X Ray PA view or invalid Chest X ray PA view (after 01 year of validity).
- •Any clinically significant abnormality in ECG.
- •Regular use of tobacco or nicotine in significant amount in any form (e.g. use of equal to or more than 5 cigarettes a day) or have difficulty in abstaining from (smoking) nicotine use for the entire duration of the study.
- •History of drug dependence or excessive alcohol intake on a habitual basis, or, inability to abstain from alcohol for the entire duration of study.
- •History or presence of significant gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological, hematologic, or endocrine disease.
- •History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension, glaucoma etc.
- •Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, tetrahydrocannabinol, morphine, and cocaine) in urine
- •Positive for urine alcohol.
- •History or presence of any psychiatric illness including Symptoms of Depression or mania (Sleep Disturbances, Interest pleasure reduction, Guilt feelings or thoughts of worthlessness, energy changes fatigue, concentration attention impairment, appetite weight changes, psychomotor disturbances and having thoughts of suicide) and or intake of any anti-depressant medications.
- •History or presence of any allergic illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g., NSAIDs.
- •History of intake administration of any investigational treatment in a clinical study within last 90 days prior to the onset of the study admission of period I of the study
- •History of significant blood loss (more than 350 mL) due to any reason, including blood donation within last 90 days prior to admission of period I of the study.
- •Existence of any surgical or medical condition which in the judgement of principal investigator designee might interfere with the absorption, distribution, metabolism or elimination of the study drug, or, is likely to compromise the safety of subject.
- •• Anticoagulants and Antiplatelets (e.g., Warfarin, Aspirin, Clopidogrel, Heparin): May enhance the risk of bleeding due to omega 3 mild antiplatelet effect.
- •Monitoring is required for individuals on blood thinners.
- •• Antihypertensive Drugs (e.g., ACE inhibitors, Beta blockers, Calcium channel blockers, Diuretics): Omega 3 fatty acids may enhance blood pressure lowering effects, increasing the risk of hypotension.
- •• Lipid lowering Agents (e.g., Statins, Fibrates, Ezetimibe) May have an additive effect in reducing triglycerides but could also slightly raise LDL cholesterol in some individuals.
- •• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) (e.g., Ibuprofen, Naproxen, Diclofenac) May increase the risk of bleeding when combined due to their overlapping effects on platelet function.
- •• Oral Hypoglycemic Agents and Insulin (e.g., Metformin, Sulfonylureas, Insulin) Omega 3 fatty acids may improve insulin sensitivity, which could enhance the glucose lowering effects of these medications, requiring dosage adjustments.
- •• Hormone Therapy and Oral Contraceptives Estrogen containing contraceptives or hormone replacement therapy may counteract the triglyceride lowering effect of omega 3 fatty acids.
- •Intake of unusual diet for two weeks prior to admission of period I and not willing to avoid consumption of such diet till the completion of close out visit of the study.
- •In such cases, subject selection will be at the discretion of the Principal Investigator or designee.
- •Difficulty in swallowing capsules.
结局指标
主要结局
To compare the bioavailability, to characterize the pharmacokinetic profile of the Test Product (T) [Vytals Fish Oil SMEDs Softgel Capsule (Each 1 g softgel contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India] with Reference Product (R) [Plain Fish Oil Softgel Capsule (Each 750mg softgel capsule contain 338mg EPA and 225mg DHA) of Alder Biochem Private Limited, India]
时间窗: Subjects will visit at study site at period I and period II with the 07 days wash out period and each period Samples will be collected at Pre-dose (0.00) and 0.50, 1.00, 2.00, 4.00, 6.00, 8.00, 10.00, 12.00, 14.00, 16.00, 18.00 and 24.00 hours post dose.
次要结局
- Safety of the study subjects will also be monitored and evaluated.(Sitting blood pressure, pulse rate, respiratory rate, and body surface temperature will be recorded at check-in and before check-out in each period. Measurements of blood pressure, pulse rate, and body surface temperature will be taken in sitting/supine position at pre-dose (0:00), and at 3, 5, 6, 8, 12, and 24 hours (±40 minutes) post-dose.)
研究者
Dr Shashi Kumar Singh
Mediclin Clinical Services Private Limited