CTRI/2019/07/020467已完成未知
A double-blind, randomized, balanced, two-treatments, two-sequence, two-period, two-way crossover, single dose oral comparative bioavailability study of OLNP-18 (Test product) with Standard curcuminoids (Reference product) following oral administration of hard gelatin capsules in normal, healthy, adult, human male study participants under fasting conditions.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 18
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 Subject should provide written informed consent.
- •2 Subject must be a normal, healthy, adult human male 18 to 45 years of age.
- •3 Subject willing to consume 8 capsules of investigational product per period with 300 ± 2mL of water.
- •4 Subject should have a Body Mass Index of 18.5 kg/m2 to 24.9 kg/m2 with body weight at least 55 kg for men.
- •5 Subject should have a systolic blood pressure with an upper limit of less than 140 mmHg and lower limit of more than or equal to 100 mm Hg. Similarly diastolic blood pressure with an upper limit less than 90 mm Hg and lower limit more than or equal to 70 mmHg.
- •6 Subject should have heart rate not less than 60 beats/min and not more than 100 beats/min and respiratory rate not less than 14/min and not more than 18/min.
- •7 Subjects should be willing to take turmeric free food for the entire study duration
- •8 Subject must be of normal health as determined by medical history and physical examination performed within 21 days prior to the dosing of period-I.
- •9 Subject should have clinically insignificant ECG, chest X-ray and vital signs.
- •10 Availability of a study volunteer for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •11 With negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
排除标准
- •1 Subject is incapable of understanding the informed consent.
- •2 Subject having History of difficulty in swallowing capsules.
- •3 Subject has a history of hypersensitivity or idiosyncratic reaction to turmeric and active or inactive ingredient in the OLNP-18 or any other related product.
- •4 Subject has any evidence of impairment of renal, hepatic, cardiac, pulmonary or gastrointestinal function. Study volunteers with a history of tuberculosis, epilepsy, asthm, diabetes, psychosis or eye disorders will not be eligible for the study.
- •5 Subject regularly smokes more than 10 cigarettes daily or has difficulty in abstaining from tobacco for the duration of the study period.
- •6 Subject has taken over the counter or prescribed medications, including any enzyme modifying drugs (known to induce or inhibit hepatic enzyme activity) or any systemic medication within the past 30 days prior to dosing in first period.
- •7 Subject has a history of any psychiatric illness, which may impair the ability to provide written, informed consent.
- •8 Subject has a history of alcohol or substance abuse within the last 5 years.
- •9 Subject has clinically significant abnormal values of laboratory parameters.
- •10 Subject has participated in any other clinical investigation using experimental drug/product or had bled more than 350 mL in the past 03 months.
- •11 Subject is unable to or unlikely to be compliant with protocol requirements or restrictions.
- •12 Subject, in whom study product is contraindicated for medical reasons
- •13 Any other clinical condition like diarrhea or vomiting within 3 days prior to dosing;
- •14 Use of any curcumin-containing supplements or foods containing high concentrations of curcumin within 14 days prior to dosing;
- •15 Use of any OTC products within 14 days or within 5 half-lives of the drug, whichever is longer prior to dosing and throughout study;
- •16 History or presence of significant gastric and/or duodenal ulceration;
- •17 Use of any recreational drug or history of drug addiction
- •18 Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to dosing in each study period and throughout sampling time points;
- •19 Consumption of grapefruit or its juice within 72.00 hours prior to dosing in each study period and throughout sampling time points;
- •20 Subject is intolerant to venipuncture.
研究者
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