Pharmacology study of SUN Pharmas Dry powder inhaler in patients with moderate to severe asthma
Not Applicable
- Conditions
- Health Condition 1: null- Asthma patientsHealth Condition 2: J459- Other and unspecified asthma
- Registration Number
- CTRI/2014/07/004752
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Asthmatic subjects, 18 years of age or older
-Having no evidence of underlying disease (except asthma)
-Willing to sign the informed consent form
-Ability to use the dry powder inhaler correctly.
Exclusion Criteria
-Having history of clinically significant gastrointestinal, dermatological, cardiovascular,
renal, hematological, psychiatric, cerebrovascular, neurological, hepatic, pulmonary
-Having hypersensitivity or allergy to ingredients of the IP
-Subjects determined by the study physician to have any medical condition that could jeopardize
their health or prejudice the results
-Females who are pregnant, breastfeeding, or are likely to become pregnant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC 0-t , CmaxTimepoint: 24-hours post dose
- Secondary Outcome Measures
Name Time Method AUC0-inf, tmax, t1/2, KelTimepoint: 24 hours pre-dose and up to 24 hours post-dose