CTRI/2017/12/010894已完成未知
Evaluation Of Plasma Concentrations Of Boswellic Acids In Fasting Healthy Human Subjects Supplemented With A Test Product AquaLOX (Standardized To 78% AKBA) In Comparison With A Reference Product 5-Loxin® (Standardized To 30% AKBA)
aila Nutraceuticals0 个研究点目标入组 22 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
- 22
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.Normal, healthy, adult, human subjects of age between 18-45 years with a Body Mass Index (BMI) ranges between 18.50 kg/m2 to 24.99 kg/m2 .
- •2.Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 29 days of check-in.
- •3.Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance.
- •4.Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
- •5.Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
- •6.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
- •7.Willing to consume Ova lacto-vegetarian diet.
- •8.Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
- •9.Negative alcohol breath analysis (to be performed on the day of check-in for the study).
- •10.Subjects with negative test result for drug of abuse (to be performed on the day of check-in for the study).
- •11.Negative urine test for pregnancy during screening and on the day of check-in for the study (for female volunteers).
- •12.Vital parameters - BP should be within the range of 100 â?? 139 mmHg systolic and 60 â?? 89 mmHg diastolic. Pulse rate should be within the range of 60 â?? 100 / min. Oral temperature between 97.8Ë? F and 99.0Ë? F.
- •13.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)] from at least 2 months prior to study entry and through the duration of the study.
- •14.Females who are Postmenopausal for at least 1 year, orsurgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed on the subject).
排除标准
- •1.Subjects incapable of understanding the informed consent.
- •2.History of any major surgical procedure in the past 03 months.
- •3.History of diabetes mellitus, tuberculosis and systemic hypertension.
- •4.History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, neurological, metabolic, or hematological disorders judged to be clinically significant.
- •5.History of dysphagia.
- •6.History of any medical disorder that is of significance in the investigatorâ??s opinion.
- •7.Alcohol dependence, alcohol abuse or drug abuse with any recreational drug within past one year.
- •8.Smoking >= 10 cigarettes/day or consumption of tobacco products >= 4 chews/day.
- •9.Use of enzyme-modifying drugs like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc in the previous 30 days before check in day.
- •10.Systemic corticosteroid use within the past 6 months.
- •11.Presence of a non-healing wound, ulcer, fracture, or any medical condition associated with bleeding.
- •12.Loss, donation, or removal of 400 mL or more of blood within the past 3 months.
- •13.Women who are pregnant or breastfeeding, or non-sterile or premenopausal women who refuse to use two proven methods of contraception during and for at least 2 weeks following the final dose of study drug.
- •14.Enrollment in another investigational drug or device study within 3 months of study entry.
- •15.Ongoing cardiac arrhythmias or prolongation of the QTc interval to > 450 m sec for males or > 470 m sec for females.
- •16.Known liver, kidney, cardiovascular, neurologic, or pulmonary disease; treated or untreated hypertension; current or history of drug or alcohol abuse.
- •17.Known human immunodeficiency virus-or acquired immunodeficiency syndrome-related illness
- •18.Positive test for Hepatitis A, B and C or any other liver abnormalities including jaundice
- •19.Other severe acute or chronic medical or psychiatric conditions that may increase the risk associated with study participation or study drug administration
- •20.Subjects with clinically significant abnormal values of laboratory parameters
- •21.Positive results for drugs of abuse (benzodiazepines, cocaine, opioids, amphetamines, cannabinoids and barbiturates) in urine during the study check-in of each period
- •22.Positive results for alcohol breath analysis during the study check-in of each period
- •23.Female volunteer demonstrating a positive pregnancy test
- •24.Female volunteer who is pregnant, currently breast-feeding or who is likely to become pregnant during the study
- •25.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing
- •26.Use of any prescribed medication or OTC medicinal products during last two weeks preceding the first dosing
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