None listed
Conditions
Interventions
Intervention1: Inhaled dry powder radiolabelled budesonide / formoterol (200 / 6 mcg): 1 Capsule: Budesonide / Formoterol (200 / 6 mcg) per day for 1 day
Control Intervention1: Nil: Mil
Sponsors
Glenmark Pharmaceuticals Ltd.,
Glenmark House,
HDO-Corporate Building,
Wing-A, B.D. Sawant Marg, Chakala,
Off Western Express Highway,
Andheri (E) Mumbai 400099.
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scintigraphy for local lung depositionTimepoint: Till 8 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: AT the end of 48 hours | — |
Countries
India
Contacts
Public ContactDr. Shilpa Karkera
Outcome results
None listed