NCT01120912已完成1 期
A Single Center, Non-randomized, Single Blind, Placebo Controlled, Single Dose Study of the Safety and Efficacy of Single Administration of Oshadi Oral Insulin in Type I Diabetes Patients - Phase 1 Study
Oshadi Drug Administration1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Adverse events occurrence
研究概览
简要总结
The study will be a non-randomized, open label, single dose, single blind, placebo control, single center, single arm study in Type I diabetes patients. The study will include single dose administration for the evaluation of single dose acute toxicity, pharmacokinetics and activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable type I diabetes mellitus.
- •Male/female 18 years old and up.
- •Glucose level is treated only by s.c basal/bolus insulin injection (not by insulin pump) at least 48 hours prior to study initiation.
- •Patients must understand and be willing to give written informed consent prior to any study procedures or evaluations and be willing to adhere to all study schedules and requirements.
- •Patients must be sterile or infertile or use an approved method of contraception from the time that the first dose of study medication is taken until three months following study completion or discontinuation.
排除标准
- •Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease which in the judgment of the investigator would interfere with the study or confound the results.
- •Patients with positive HIV serology or positive HBsAg at screening.
- •History or evidence of any active liver disease.
- •C-peptide > 3 mg/ml (fasting).
- •Female patients who are breastfeeding or have a positive pregnancy test at screening or at any time during the study.
- •Inability to give written informed consent.
- •History of alcohol or drug abuse within 6 months of screening.
- •Patients who have a positive urine drug screen for substances of abuse (benzodiazepine, THC, opiates, amphetamines, cocaine) at the screening.
- •Mental disorders.
- •Patients with poor venous access.
- •Significant swallowing disorders.
- •Digestive disorders.
- •Small bowel surgery.
- •Mall absorption disorders.
研究组 & 干预措施
Oral insulin and placebo
Experimental
干预措施: Oshadi Oral Insulin (Drug)
结局指标
主要结局
Adverse events occurrence
时间窗: one month
次要结局
- Evaluate the glucose lowering effect of Oshadi Oral Insulin(12 hours following administration)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of the Influence of Food Regimen on Oshadi D AbsorptionLupus Erythematosus, SystemicNCT01327352Oshadi Drug Administration8
已完成
1 期
To Evaluate the Safety, Tolerability, Pulmonary Deposition, Pharmacokinetics and Pharmacodynamics of Ciprofloxacin Inhale in Japanese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD, GOLD II-III)Pulmonary Disease, Chronic ObstructiveNCT01072942Bayer16
已完成
1 期
A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese SubjectsHealthy SubjectsNCT02289599Eisai Co., Ltd.24
已完成
早期 1 期
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male SubjectsNASH With FibrosisNCT05737433Hepion Pharmaceuticals, Inc.6
已完成
1 期
A Study of the Metabolic Profile of Dalcetrapib in Healthy VolunteersHealthy VolunteerNCT01476267Hoffmann-La Roche6