CTRI/2024/09/074434已完成不适用
An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Pharmacokinetic Study Comparing Cinnamon Bark Extract W Capsules 15 mg cinnamaldehyde capsule Manufactured by Nutriventia Limited With Cinnamon Bark Extract Capsules 30 mg cinnamaldehyde capsule manufactured by Synthite Industries Private Limited In Healthy Adult Human Male Subjects Under Fasting Conditions
Nutriventia Limited1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年10月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the Oral Pharmacokinetic of Cinnamon Bark Extract W Capsules 15 mg cinnamaldehyde per capsule Manufactured by Nutriventia Limited with Cinnamon Bark Extract Capsules 30 mg cinnamaldehyde capsule manufactured by Synthite Industries Private Limited in Healthy Adult Human Male Subjects Under Fasting Conditions
研究概览
简要总结
At least 12 healthy, adult, human male subjects will be recruited to evaluate the Pharmacokinetic of Test product with the Reference product
In each period, subjects will be housed in the clinical facility for at least -36.00 hours pre-dose to 36.00 hours post dose. A washout period of at least 07 days will be maintained between each dosing period.
Monitoring for adverse events will be done throughout the study period in the clinical phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Normal healthy adult human male subjects of age between 18 to 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 29.99 kg/m2 Subjects willing to follow diets free of cinnamon and any spice mixtures containing cinnamon starting at least 7 days before period I check in till end of period II including entire study period Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in Subjects whose screening laboratory values are within normal limits are considered by the physician or principal clinical investigator to be of no clinical significance Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments Generally healthy as documented by a 12 lead electrocardiogram ECG Chest X Ray and clinical laboratory assessments Willing to consume Ovo lacto vegetarian diet Willing to comply with all requirements of this study protocol as well as instructions from the study personnel Non smokers.
排除标准
- •Evidence of allergy or known hypersensitivity to cinnamaldehyde or its inactive ingredients Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease Any major illness in the last three months or any significant on going chronic medical illness Renal or liver impairment Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis History of alcohol addiction or abuse Consumption of caffeine and or xanthine containing cigarettes and tobacco containing products for at least 48 00 hours prior to check-in and throughout the entire study Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48 00 hours prior to clinic admission and throughout the entire study Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications within 14 days prior to study check in and throughout the study Subjects who have taken any unusual diet for whatever reason low salt for 48 00 hours prior to dosing and throughout the study Subject who had participated in any other study within the 90 days of check in History of difficulty in swallowing History of difficulty in accessibility of veins Positive results for urine screen of drugs of abuse Marijuana THC amphetamine AMP barbiturates BAR cocaine COC benzodiazepines BZD and morphine MOR in urine prior to check in of each period Positive results for alcohol test prior to check in of each period Any blood donation excess blood loss within 90 days of check in Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in Use of hormone replacement therapy for a period of 06 months prior to dosing.
结局指标
主要结局
To assess the Oral Pharmacokinetic of Cinnamon Bark Extract W Capsules 15 mg cinnamaldehyde per capsule Manufactured by Nutriventia Limited with Cinnamon Bark Extract Capsules 30 mg cinnamaldehyde capsule manufactured by Synthite Industries Private Limited in Healthy Adult Human Male Subjects Under Fasting Conditions
时间窗: 22 samples | –12 00 hrs –02 00 hrs 00 00 hrs 00 17 hrs 00 33 hrs 00 50 hrs 00 67 hrs 01 00 hrs 01 25 hrs 01 50 hrs 02 00 hrs 02 50 hrs 03 00 hrs 03 50 hrs 04 00 hrs 05 00 hrs 06 00 hrs 08 00 hrs 10 00 hrs 12 00 hrs 24 00 hrs 36 00 hrs
次要结局
- To monitor the safety & tolerability of test product comparing with the reference product in Healthy Adult Human Male Subjects Under Fasting Conditions(22 Samples)
研究者
Dr Pradeep T
Spinos Life science and research private limited
研究点 (1)
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