A study to find out the difference in absorption of same dose of drug prepared in 2 different forms, given one followed by the other to the same person

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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000628

Enrollment

Registered

2009-09-01

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: AEB071 Coated tablet: Single dose administration Control Intervention1: AEB071 capsule: Single dose administration

Eligibility

Inclusion criteria

Inclusion criteria: Health volunteers of either gender between 18 to 45 years. Women should be postmenopausal or surgically sterialized Males should be using contraception

Exclusion criteria

Exclusion criteria: Smokers History of any major illness, and abnormal lab assessment Those who have intension to vaccine for 2 weeks or have had vaccine in the last 2 weeks

Design outcomes

Primary

Measure	Time frame
To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsuleTimepoint: NIL	—

Secondary

Measure	Time frame
To assess the safety and tolerability of AEB071 after single-dose administrations Timepoint: NIL	—

Countries

India

Contacts

Public ContactDr. Vinu Jose

Novartis Healthcare Private Limited

vinu.jose@novartis.com04067672946

Outcome results