To determine the relative concentration of inhaled indacaterol maleate (with andwithout oral activated charcoal) in blood of the subjects through concept1 device and the EPIC TestFixture in healthy adult subjects.
Phase 1
Completed
- Registration Number
- CTRI/2013/07/003811
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Healthy male and female subjects
2. Subjects must weigh at least 50 kg and their BMI should be within range of 18-30 kg/m2
3. Women of child-bearing potential must use effective contraception during the study.
Exclusion Criteria
1.Smokers
2.History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
3.Pregnant or nursing (lactating) women.
4.Known family history or known presence of long QT syndrome
5.Known history or current clinically significant arrhythmias.
6.History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the derived Flung (ratio of AUC with oral activated charcoal (AC) to that without activated charcoal; indirect measure of indacaterol lung deposition) of a single inhaled dose of indacaterol (300 μg) delivered via the EPIC Test Fixture with that delivered via the Concept1 device.Timepoint: during the study
- Secondary Outcome Measures
Name Time Method 1.To assess the pharmacokinetics of indacaterol after orally inhaled 300 μg of indacaterol when delivered via the EPIC Test Fixture. <br/ ><br>2. To assess the safety and tolerability of indacaterol after orally inhaled <br/ ><br>300 μg of indacaterol delivered via the EPIC Test Fixture <br/ ><br>3. To perform Pharmacogenetic assessmentTimepoint: Monitoring of AE from enrolment until 30 days after stopping the trial/study drug