A clinical trial to study the lung deposition of a dry powder formulations (DPI)in healthy adult male volunteers
- Registration Number
- CTRI/2010/091/002950
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd.,Glenmark House,HDO-Corporate Building,Wing-A, B.D. Sawant Marg, Chakala,Off Western Express Highway,Andheri (E) Mumbai 400099.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 10
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method