CTRI/2014/01/004328已完成未知
A Prospective, Open Label, Randomised, Comparative, Crossover Clinical Study to Evaluate the Taste and Sensation Effects of Nimorazole 200mg mouth dissolving tablet (F4 formulation) and Nimoral® 500mg tablet manufactured for DeVats (India) Private Limited, New Delhi in Clinically Healthy Adults.
DeVats India Private Limited0 个研究点目标入组 6 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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.Clinically healthy adults between the ages of 18 and 50 (both sexes)
- •2.Subject who understand and willing to sign informed consent document before start of any study specific assessment.
- •3.Subject has not participated in a similar investigation in the past four weeks.
排除标准
- •1.Subject who have known history of misplaced taste perceptions
- •2.Subjects who are smokers or have quit smoking within the last 6 months.
- •3.Subjects who are currently having or recently has upper respiratory or middle ear infections
- •4.Subjects who have recently undergone chemotherapy/ radiation treatment for head and neck cancers.
- •5.Subjects with recent surgeries to the ear, nose, throat including wisdom tooth extraction in the past 4 weeks.
- •6.Subjects with Olfactory disorders such as anosmia, partial anosmia, hyposmia, hyperosmia, dysosmia, phantosmia, olfactory agnosia.
- •7.Subjects with poor oral hygiene, mouth ulcers or other dental problems such as gingival or periodontal infections.
- •8.Subjects with history of thyroid imbalances.
- •9.Subjects who are on treatment with DMARD, anti inflammatory drugs, immunosuppresents for the past 6 months before inclusion into the trial.
- •10.Subjects who are planning a pregnancy, reported pregnant or lactating.
- •11.Subjects, who in the opinion of the Investigator are not eligible for enrollment in the study.
研究者
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