Evaluation of Pharmacokinetic Interaction of Indacaterol With Ketoconazole in Healthy Adult Subjects
This study has been completed.
Information provided by:
First received: December 12, 2006
Last updated: June 18, 2007
Last verified: June 2007
This study will evaluate the interaction potential between indacaterol and ketoconazole (a potent CYP3A inhibitor) in healthy adult subjects.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label, Single Dose, Two Period, Single Sequence Crossover Study to Assess the Pharmacokinetic Interaction of QAB149 (300 Mcg Via Inhalation) With Ketoconazole (200 mg Tablet b.i.d.) in Healthy Adult Subjects|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Pharmacokinetics of a single 300 µg dose of indacaterol (QAB149) alone administered via inhalation and in the presence of ketoconazole (at steady state) in healthy adult subjects
Secondary Outcome Measures:
- Safety of a single 300 µg dose of indacaterol (QAB149) given via inhalation in the presence of ketoconazole at steady state in healthy adult subjects.
|Study Start Date:||December 2006|
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