CTRI/2022/05/042912尚未招募未知
A randomized, single-dose, double-blind, placebo-controlled, ascending dose, 4-way crossover study to evaluate the analgesic effects of ViphyllinTM in healthy volunteers.
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
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. Should not be on any regular medications or supplementation for pain.
- •2. Must be willing and able to give informed consent and comply with the study procedures.
- •3. Should be ready to abstain from alcohol consumption, smoking and consumption of caffeinated beverages.
排除标准
- •1.Subjects who are experiencing pain currently due to any cause or with history of acute or chronic pain.
- •2. Subject with ability to withstand the CPT for the maximum 3 minutes (to avoid a ceiling effect).
- •3. Subjects having symptoms of viral infection, including COVID-19 infection
- •4. Subject with clinically significant abnormalities in blood pressure, heart rate, ECG recording and laboratory parameters
- •5. Regularly on over the counter or prescribed medication
- •6. Subjects with known hypersensitivity to the investigational products.
- •7. Alcohol/drug addicts, smokers of more than 10 cigarettes/day.
- •8. Pregnant and lactating women
- •9. Currently participating or having participated in another clinical trial during the last 1 month prior to the beginning of this study
- •10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
研究者
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