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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00410501 |
Purpose
This study will evaluate the interaction potential between indacaterol and ketoconazole (a potent CYP3A inhibitor) in healthy adult subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Indacaterol (QAB149) |
Phase I |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 20 |
| Study Start Date: | December 2006 |
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00410501 History of Changes |
| Other Study ID Numbers: | CQAB149A2311 |
| Study First Received: | December 12, 2006 |
| Last Updated: | June 18, 2007 |
| Health Authority: | India: Drug Controller General |
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Pharmacokinetics, interaction, QAB149, indacaterol, ketoconazole, healthy subjects |
|
Ketoconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |