FindTrial
Sign In

To determine the relative bioavailability of indacaterol lactose blend formulation and a Pulmosphere blend formulation in healthy adult subjects

A randomized, open label study to determine the relative bioavailability of inhaled indacaterol given with and without oral activated charcoal for two formulations of indacaterol- lactose blend formulation and Pulmosphere based formulation in healthy adult subjects.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/04/002546
Enrollment
40
Registered
2012-04-04
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- Pulmosphereâ?¢ (75 microgram) capsules with and without activated charcoal: Single dose Control Intervention1: Indacaterol-Lactose blend (150microgram )capsules with and wi

Sponsors

Novartis Healthcare Private Limited
Lead Sponsor

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. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result, HIV test 5. History of clinically significant ECG abnormalities, malignancy of any organ system, history of immunodeficiency diseases; of drug or alcohol abuse.

Design outcomes

Primary

MeasureTime frame
To compare the fraction (flung, ratio of AUC, or Cmax with activated to that without activated charcoal of systemic exposure of inhaled indacaterol for the indacaterol Pulmosphereâ?¢ formulation with that of the indacaterol lactose blend formulation.Timepoint: Four single dose treatment period, separated by 3 washout periods of 21-28 days followed by a study completion evaluation approximately 168 hours after the last drug administration.—

Secondary

MeasureTime frame
1. To access the pharmacokinetics of indacaterol, given together with and without activated charcoal, when delivered as lactose blended or Pulmosphereâ?¢ formulations. 2. To assess the safety and tolerability of indacaterol in healthy subjects. 3. To perform pharmacogenetic assessment. Timepoint: Monitoring of AE from providing the written informed consent form until 30 days after stopping the trial.—

Countries

India

Contacts

Public ContactShibadas Biswal

Novartis Healthcare Pvt. Ltd.

shibadas.biswal@novartis.com04067673287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026