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Clinical Trials/CTRI/2009/091/000628
CTRI/2009/091/000628
Unknown
Phase 1/2

An open-label, randomized, 2-period, cross-over study to determine the relative bioavailability of AEB071 from a coated tablet versus a capsule in healthy subjects

Novartis Healthcare Private Limited1 site in 1 country16 target enrollmentStarted: TBD
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Overview

Phase
Phase 1/2
Enrollment
16
Locations
1
Primary Endpoint
To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsule
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

An open-label, randomized, 2-period, cross-over study to determine the relative bioavailability of AEB071 from a tablet formulation versus a capsule formulation in healthy subjects. Results will be used to guide formulation development decisions.

Study Design

Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Inclusion Criteria

  • •Health volunteers of either gender between 18 to 45 years.Women should be postmenopausal or surgically sterializedMales should be using contraception.

Exclusion Criteria

  • •SmokersHistory of any major illness, and abnormal lab assessmentThose who have intension to vaccine for 2 weeks or have had vaccine in the last 2 weeks.

Outcomes

Primary Outcomes

To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsule

Time Frame: NIL

Secondary Outcomes

  • To assess the safety and tolerability of AEB071 after single-dose administrations(NIL)

Investigators

Study Sites (1)

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