NL-OMON51112已完成不适用
An open-label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, oral dissolution study to assess sugar free and sugared cetylpyridinium chloride (CPC-1.4mg) and benzocaine (10mg) lozenges in healthy subjects - CS0353-200147
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Subject has provided written informed consent.
- •Subject is male or female and aged: 18 years to 55 years.
- •Subject has a Body Mass Index (BMI) of * 18.5 and * 30.0 kg / m2
- •Subject is healthy and free of clinically significant abnormal findings as
- •determined by medical history, physical examination and vital signs.
排除标准
- •Female subject who is pregnant as confirmed by a positive pregnancy test or is
- •Subject has a current and previous clinically significant medical history as
- •deemed by the Investigator including but not limited to cardiovascular,
- •salivary gland disorders (e.g. xerostomia, Sjogren*s syndrome, drooling of
- •saliva, stones or infections), respiratory, gastro-intestinal (nausea or
- •vomiting), neurological, metabolic and psychiatric disorders.
- •Subject has oral mucosal damage (erythema/ulceration/induration) or presence of
- •clinically significant sore throat, gingivitis, or oral thrush.
- •Subjects with any oromucosal conditions or salivary gland conditions that
- •affect saliva production.
- •Subject has toothache, is intended to have dental surgery or teeth treatment
- •within 14 days prior to the first drug administration to end of study.
研究者
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