To determine the relative concentration of inhaled indacaterol maleate (with and without oral activated charcoal) in blood of the subjects through concept1 device and the EPIC Test Fixture in healthy adult subjects.

A randomized, open-label study to determine the relative bioavailability of inhaled indacaterol maleate (with and without oral activated charcoal) delivered via the EPIC Test Fixture in healthy adult subjects.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003811

Enrollment

Registered

2013-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: indacaterol(300 Î¼g)with and without activated charcoal: Single dose Control Intervention1: EPIC Test Fixture: To be used to deliver single dose of indacaterol (300 Î¼g) Control Interv

Eligibility

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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 Î¼g) delivered via the EPIC Test Fixture with that delivered via the Concept1 device.Timepoint: during the study	—

Secondary

Measure	Time frame
1.To assess the pharmacokinetics of indacaterol after orally inhaled 300 Î¼g of indacaterol when delivered via the EPIC Test Fixture. 2. To assess the safety and tolerability of indacaterol after orally inhaled 300 Î¼g of indacaterol delivered via the EPIC Test Fixture 3. To perform Pharmacogenetic assessmentTimepoint: Monitoring of AE from enrolment until 30 days after stopping the trial/study drug	—

Measure

Time frame

1.To assess the pharmacokinetics of indacaterol after orally inhaled 300 Î¼g of indacaterol when delivered via the EPIC Test Fixture. 2. To assess the safety and tolerability of indacaterol after orally inhaled 300 Î¼g of indacaterol delivered via the EPIC Test Fixture 3. To perform Pharmacogenetic assessmentTimepoint: Monitoring of AE from enrolment until 30 days after stopping the trial/study drug

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Countries

India

Contacts

Public ContactShibadas Biswal

Novartis Healthcare Pvt. Ltd.

shibadas.Biswal@novartis.com04067673278

Outcome results