CTRI/2020/03/023718已完成未知
A randomized open-label single dose two treatment two-period two sequence crossover comparative pharmacokinetic study of Vitamin E 400 mg capsules dl-alpha-Tocopheryl acetate of Troikaa Pharmaceuticals Ltd India with Evion capsules dl-alpha-Tocopheryl acetate 400 mg of Merck Sereno India in normal healthy adult human subjects under fasting conditions
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
- •Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2 (both inclusive)
- •Subjects who are able to understand and willing to comply with the protocol requirements
- •Subjects who are able to understand willing to voluntarily provide written informed consent
- •Subjects who are able to understand and willing to adhere to protocol and the following study requirements
- •Should not consume xanthine containing products such as coffee tea chocolate or soft drinks at least 24 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection
- •Should not consume grapefruit or its products at least 7 days prior to dosing (i.e. in-house monitoring and the remaining based on history) and until the last sample collection
- •Subjects who are non-alcoholic, non-smokers and not consuming any tobacco products (based on history)
排除标准
- •Subjects incapable of understanding and signing the informed consent document
- •Pregnant and lactating women (currently breast-feeding) Presence of pregnancy will be confirmed by Serum (β) Beta- hCG (Human Chorionic Gonadotropin) test before check-in
- •Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria at least 14 days prior to the first dose of study medication until the post-study follow-up. Use of hormonal contraceptives either oral or implants will not be acceptable
- •Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study
- •Subjects with abnormalities in resting heart rate ( >100 beats/min or <50 beats/min) and blood pressure either hypotensive episode (systolic blood pressure <90 mmHg or diastolic blood pressure <60 mmHg) or hypertension (systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg) on the screening day
研究者
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