CTRI/2024/03/063647尚未招募2 期
A Double blinded, randomized, three treatment, three sequence, three period, cross-over, single-dose oral bioavailability study (Comparative pharmacokinetics study) of Fish oil Capsules containing Omega-3 fatty acids (EPA ethyl ester and DHA ethyl ester) with/without advanced technology. - NA
Amway Global Services India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Volunteers who accept for participating in this study must:
- •1. Healthy, adult male, subjects aged between 18-45 years (both inclusive) at the
- •time of screening.
- •2. Having a Body Mass Index (BMI) between 18.50 to 24.99 kg/m2 (both inclusive) at the time of screening.
- •3. Normal or clinically insignificant findings during screening, medical history,
- •clinical examination including vital signs, laboratory evaluations, 12 lead
- •ECG and X-ray chest (posterior-anterior view) recordings.
- •4. Able to comply with the study procedures, in the opinion of the principal
- •investigator.
- •5. Compliance with study specific restrictions and prohibitions.
- •6. Able to give voluntary written informed consent for participation in the trial.
- •7. Complying to avoid fish the previous day as well as for the entire study period
排除标准
- •If any subject is having any of the following conditions, then exclude him from
- •participation in this study:
- •1. Known hypersensitivity or idiosyncratic reaction to the study Investigational
- •product or any related Product.
- •2. Regular user of supplements containing Omega-3 fatty acid
- •3. History or presence of any disease or disorder known to influence bone
- •metabolism, compromise the hemopoietin, renal, hepatic, endocrine,
- •pulmonary, central nervous, cardiovascular, immunological, dermatological,
- •gastrointestinal, musculoskeletal or any other body system.
- •4. Ingestion of any medicine at any time within 14 days prior to IP administration
- •in period I. In any such case subject selection will be at the discretion of the
- •principal investigator.
- •5. Habit of consuming high caffeine (more than 5 cups of coffee or tea/day).
- •6. Smokers and Alcoholics.
- •7. History of dehydration from diarrhea, vomiting or any other reason within a
- •period of 24.00 hours prior to study check-in
- •8. An unusual or abnormal diet within 48.00 hours prior to study check-in,
- •whatever reason e.g. because of fasting due to religious reasons.
- •9. People consuming fish in their diet 7 days prior to the study.
- •10. The presence of clinically significant abnormal laboratory values during
- •11. Use of any recreational Products or history of Product addiction or testing
- •positive in pre-study urine drug screening and Urine alcohol test.
- •12. A history of difficulty with donating blood or having donated blood in the
- •preceding 90 days for males prior to the start of the study.
- •13.Subject who has participated in any other clinical study involving
- •Investigational product administration and collection of blood samples in the
- •90 days for males preceding the start of the study.
- •14.Difficulty in swallowing capsule.
- •15. Positive HIV, VDRL/RPR, Hepatitis B and C tests.
- •16. Subjects who have used any Products or substances known to be strong
- •inhibitors or inducers of Cytochrome P450 enzymes within 14 days prior to IP administration in period I
研究者
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