CTRI/2018/03/012451已完成1 期
Patch Test (Skin Irritation)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
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. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the written
- •informed consent.
- •2. Normal findings in the physical and clinical examinations.
- •3. Clinical Laboratory values within 10% above or below the laboratoryâ??s stated normal range, unless the investigators along with physicians decide that they are not clinically significant and record this fact on the case report form.
- •4. A Non-Smoker.
- •5. Asian males of Indian origin.
排除标准
- •1. History of hypersensitivity to the study formulations or related
- •2. Significant history or presence of psychiatric, gastro intestinal, liver
- •or kidney disorder/impairments, or any other conditions known to
- •interfere with the absorption, distribution, metabolism or excretion of
- •common medications.
- •3. Significant history of asthma, chronic bronchitis or other
- •bronchospastic condition.
- •4. Significant history or presence of glaucoma, cardiovascular or
- •hematological disease.
- •5. Any clinically significant illness during the 4 weeks prior to day one
- •of this study.
- •6. Maintenance therapy with any drug, or history of drug
- •dependency, alcohol abuse, or serious neurological or psychological
- •7. Participation in a clinical trial with an investigation drug within
- •90days preceding day 1 of the current study.
- •8. Use of enzyme-modifying drugs within 30 days prior to day 1 of
- •this study.
- •9. Use of any systemic medication (including OTC preparations)
- •within 14 days proceeding day 1 of this study.
- •10. HIV and Hepatitis and Australian Antigen positive volunteers.
研究者
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