Health Condition 1: null- Asthma patients Health Condition 2: J459- Other and unspecified asthma
Conditions
Interventions
Intervention1: Salmeterol 25 mcg and Fluticasone Propionate 250 mcg Dry Powder Inhaler: Single dose oral inhalation
Cross over study with at least 5 days washout period between two doses.
Control Intervention1: Seretide Accuhaler 50/500: Single dose oral inhalation
Cross over study with at least 5 days washout period between two doses.
Sponsors
Sun Pharma Advanced Research Company Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC 0-t , CmaxTimepoint: 24-hours post dose | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-inf, tmax, t1/2, KelTimepoint: 24 hours pre-dose and up to 24 hours post-dose | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd.
Outcome results
None listed