CTRI/2010/091/002950尚未招募4 期
A gamma scintigraphy study to compare the lung deposition and blood bioavailability of dry powder formulations for inhalation containing radiolabeled budesonide/formoterol (200/6mcg) in adult healthy volunteers
Glenmark Pharmaceuticals Ltd.,Glenmark House,HDO-Corporate Building,Wing-A, B.D. Sawant Marg, Chakala,Off Western Express Highway,Andheri (E) Mumbai 400099.0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 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
- •Healthy male volunteers with age ranging from 18 to 45 years.
- •Non-smokers with deep inspiration capacity
- •Ability to master DPI inhalation technique in dummy experiments
- •Written informed consent by volunteers
- •Volunteers willing to follow up.
排除标准
- •Volunteers unable to inhale DPI properly and with consistency
- •Patients with known hypersensitivity to budesonide or formoterol, Technetium 99 m to compounds structurally related to the study drugs or to any other component included.
- •Heavy smokers or volunteers with underlying respiratory problems interfering with vital capacity or giving rise to PFT abnormality or inconsistency
- •Volunteers with osteoporosis or any condition predisposing to low bone density
- •Volunteers having any contraindication like asthma, COPD, past history of tuberculosis
- •Volunteers with out of normal range values in any of the following laboratory blood tests: complete blood count, blood glucose, ionogram, AST, ALT, total bilirrubin, total proteins, urea, creatinine, total cholesterol and triglycerides and urine potassium levels.
- •Any other condition that in the opinion of the investigator does not justify the patient?s participation in the study
研究者
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