CTRI/2019/03/018209已完成未知
A bioavailability study of omega-3 from fish oil syrup in healthy adults under fasting Condition.
Arjuna Natural Ltd0 个研究点目标入组 16 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •1.Healthy male volunteers within 18-45 years of age (both inclusive) who have given voluntary consent and screened within 21 days prior to the first dosing day.
- •2.Body Mass Index (BMI) in the range 18.5-30 kg/m2 and weighing at least 50 kg.
- •3.Normal health as determined by medical history and physical examination, ECG, Chest X-Ray and laboratory tests performed within 21 days prior to the commencement of the study.
- •4.Screening laboratory values within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
排除标准
- •1.Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination, laboratory evaluations, ECG, & chest X-ray recording]
- •2.A depot injection or implant of any drug within 3 months prior to administration of study medication.
- •3.Intake of any investigational drug within 4 months, any allopathic drugs or herbal supplements (OTC/Prescription) containing omega-3, including any enzyme modifying drugs within the last 14 days prior to the to the initial dose of study drug.
- •4.Donated blood (1 unit or 450 mL) within 90 days prior to the initial dose of the study drug or have blood loss, excluding volume drawn at screening for this study, (<=100 mL within 30 days; <=200 mL within 60 days; >200 mL within 90 days) prior to initial dose of study drug, whichever is greater.
- •5.Presence or history of significant gastrointestinal, liver or kidney disease, or any conditions (like history of difficulty in swallowing) known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •6.History of allergic responses to omega-3, fish oil or related products containing omega-3 or any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Co-Investigator, could contraindicate the volunteerâ??s participation in this study.
- •7.Active peptic ulceration or a history of peptic ulceration.
- •8.Resting hypotension (BP <90/60) or hypertension (BP > 139 /89).
- •9.Pulse rate below 50/ min. and above 99/min.
- •10.History of clinically significant, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •11.History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •12.Those who have been hospitalized within the last 4 weeks preceding the start of the study.
- •13.A History of drug abuse or alcoholism (greater than 7 drinks/ week)
- •14.Smoker or have stopped smoking in < 1 yr.
- •15.Difficulty with donating blood or intolerance to venipuncture.
- •16.A positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission.
研究者
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