DRKS00000758已完成1 期
Oromucosal Delivery of Insulin: Proof of Concept” Using a Mucoadhesive Wafer Dosage Form Containing Insulin.A single-center study with two parts: Part 1 comparing lingual/palatal versus gingival insulin wafer administration according to an open-label, parallel-group design, and, on condition that satisfactory exposure has been achieved, Part 2 investigating positive and negative control according to a double blind, crossover design. PART 1
TS Lohmann Therapie-Systeme AG0 个研究点目标入组 14 人开始时间: 2011年7月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- Male
入选标准
- •Male subjects of any ethnic origin between 18 and 45 years of age (inclusive);
- •Non-smokers;
- •In good general physical health, determined by medical history (including exclusion of first-degree family diabetes);
- •Physical examination, electrocardiogram (ECG),
- •vital signs, clinical laboratory tests;
- •Body Mass Index within 19 to 28 kg/m2 and body weight within 69.4 to 80.6 kg (75 kg ± 7.5%);
- •Fasting venous blood glucose between 70 and 110 mg/dL (inclusive).
排除标准
- •Subjects with tendency for gum bleeding, oromucosal lesions or other oromucosal diseases;
- •Subjects with a clinical history of allergic reactions against p-Hydroxy benzoic acid esters (PHB-esters);
- •Hypersensitivity to any of the ingredients of the investigational medicinal
- •Any history of alcohol or drug abuse;
- •Any history of chronic gastritis or peptic ulcers;
- •Any history of chronic or recurrent metabolic, renal, hepatic, pulmonary,
- •gastrointestinal, neurological (esp. history of epileptic seizures), endocrinological, immunological, psychiatric or cardiovascular disease, myopathies and bleeding tendency;
- •Blood donation within 30 days prior to inclusion in this study;
- •Laboratory values outside the reference range that are of clinical relevance (e.g., suggesting an unknown disease and requiring further clinical evaluation assessed by the investigator) especially aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma glutamyl transpeptidase (gamma-GT).
研究者
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Oromucosal Delivery of Insulin: Proof of Concept” Using a Mucoadhesive Wafer Dosage Form Containing Insulin.A single-center study with two parts: Part 1 comparing lingual/palatal versus gingival insulin wafer administration according to an open-label, parallel-group design, and, on condition that satisfactory exposure has been achieved, Part 2 investigating positive and negative control according to a double blind, crossover design. PART 2This is a Phase I study, involving healthy subjects. The study is designed as a Proof of Concept to evaluate oromucosal delivery of insulin, contained in a mucoadhesive wafer.The study population in this clinical study will not benefit from the treatment. Orosomucosal delivery of insulin may be of benefit to patients with Diabetes Mellitus.E10Type 1 diabetes mellitusDRKS00003127TS Lohmann Therapie-Systeme AG14
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