CTRI/2010/091/001352已完成1 期
An open labeled, non-comparative, single centre study to assess the bioavailability and safety of atropine sulfate injected by sublingual submucosal injection in healthy human volunteers
Defence R&D Organisation0 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
- 1 期
- 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. Male healthy human volunteers, 18-65 yrs of age, body weight of 50-70kg.
排除标准
- •1. Volunteers who are unwilling to give informed consent.
- •2. Volunteers taking any medication.
- •3. Volunteers having any contraindications like increased intraocular pressure (IOP), ENT problem, unstable cardiac rhythm, tachycardia etc
- •4. Volunteers on cholinergic/anticholinergic or any treatment likely to affect local vascularity / atropinization observation.
- •5. Volunteers having apthous ulcers, oral infection / fibrosis
- •6. Chronic use of pan masala containing nicotine, chronic smoker
- •7. Volunteers who have any medical condition which in the judgment of the investigator may render them in appropriate for participation in the trial
研究者
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