CTRI/2023/05/052192已完成Unknown
An open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, two-way crossover, oral comparative bioavailability study of Ginactiv® capsule 250mg and Ginger extract capsule 250mg in healthy, adult, human subjects under fasting conditions.
Aurea Biolabs Private Limited0 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
- Unknown
- 状态
- 已完成
- 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
- •Is and will be available to participate for the entire study period and have willingness to adhere to Protocol requirements as evidenced by the written ICF duly signed by the volunteer.
- •Is a healthy human male subject in the age group between 18 to 45 years (both inclusive) and BMI must be within the range of 18.50 -30.00 Kg/m2 (both inclusive) with minimum body weight 50kg.
- •Has no evidence of any underlying disease during screening, medical history and whose physical examination is performed within 29 days prior to drug administration of Period I.
- •Has screening laboratory values within normal limits or considered by the Investigator to be of no clinical significance.
- •Agreeing not to consume food, drink and condiment containing ginger during the all duration of the study.
- •Does not have alcohol dependence, alcohol abuse or drug abuse (Amphetamines, Cocaine, Tetra Hydro Cannabinoids, Benzodiazepines, Barbiturates and Opioids) within the past one year.
- •Agrees to abstain from consuming xanthine-containing food products or beverages (chocolates, tea, coffee or cola drinks), tobacco containing products (cigarettes, pan, ghutka etc.,) and alcohol containing beverages from 72.00 hours prior to dosing of period I and during the entire study.
- •Agree to abstain from Ginger containing edible or beverage products within 03 days prior to dosing and throughout the study.
- •Is declared eligible to participate in the study by the investigator(s).
排除标准
- 未提供
研究者
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