CTRI/2019/02/017731已完成4 期
An open label, balanced, randomized, three-arms, three-period, crossover, oral bio-study to determine the effect of MB EnzymeProTM Capsule on bioavailability of whey protein in healthy, adult, human male subjects under fasting condition using in-vivo method
Bright Lifecare Private Limited0 个研究点目标入组 24 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
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
- •1.Able to read and understand and ready to provide written informed consent.
- •2. Healthy adult male human beings within the age of 18-35 years (both inclusive).
- •3. Having A Body Mass Index (BMI) in the range 20.0 - 24.0 kg/m2 (both inclusive) and weight at least 50 kg.
- •4. Must be of normal health as determined by medical history and physical examination, ECG and laboratory tests performed within 28 days prior to the commencement of the study.
- •5. Chest X-ray is normal or considered by the physician / Principal Investigator to be of no clinical significance.
- •6. Screening laboratory values are within normal limits or considered by the physician / Principal Investigator to be of no clinical significance.
- •7. Non-weight training subject who agree not to begin a new exercise program during the course of the study
排除标准
- •1.Known hypersensitivity or idiosyncratic reaction or intolerance to MB EnzymePro /Protein diet or any ingredients of the formulation or any related products as well as severe hypersensitivity reactions (like angioedema) to any drugs or food products.
- •2.Positive Breath Alcohol Analysis or Urine Drug Screen (UDS) before admission in Period-I of the study.
- •3.Resting hypotension (BP less than 90/60) or hypertension (BP greater than 139 /89).
- •4.Pulse rate below 50/ min. and above 99/min.
- •5.Clinically significant abnormal lab values / abnormal ECG and Chest X-Ray.
- •6.Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses, and syphilis.
- •7.History of Myocardial Infarction, Stroke, Peripheral Arterial Disease, GI Bleeding, Hepatic-Impairment, Renal Impairment, Epilepsy and Intracranial hemorrhage.
- •8.History of known food allergy.
- •9.History of drug abuse or alcoholism i.e. alcohol consumption greater than 2 units / day or 10 units / week (one unit of alcohol equal to 50 ml spirit or 200 ml wine or 500ml beer).
- •10.History of smoking or Tobacco consumption
- •11.History of allergy to heparin, preservatives, dyes.
- •12.Intake or administered protein supplements or any drugs or over the counter or prescribed medications including any enzyme modifying drugs within the last 14 days prior to the study drug administration in the study.
- •13.Suffered with any illness or who have been hospitalized within the last 4 weeks preceding the start of the study.
- •14.History or presence of significant gastrointestinal, liver or kidney disease, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
- •15.Presence of active peptic ulceration or a history of peptic ulceration.
- •16.History of clinically significant, Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- •17.Participated in any other clinical trial requiring repeated blood sampling or a blood donation program or blood loss of more than 350 ml, in the past three months (approx. 90 days) (This 350 mL includes the total blood loss that will occur during the study).
- •18.Difficulty with donating blood.
- •19.Difficulty in swallowing of Tablet and Capsules.
- •20.Following any particular protein-rich dietary regime, muscle toning or body building program or not willing to discontinue such regime or program during the conduct of study.
研究者
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