CTRI/2013/07/003811CompletedPhase 1
A randomized, open-label study to determine the relativebioavailability of inhaled indacaterol maleate (with andwithout oral activated charcoal) delivered via the EPIC TestFixture in healthy adult subjects.
ovartis Healthcare Private Limited0 sites24 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Ba/be
Eligibility Criteria
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
- •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.
Investigators
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