| CTRI Number |
CTRI/2009/091/000628 [Registered on: 01/09/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
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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 |
|
Scientific Title of Study
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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 |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CAEB071A2215 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. S. T. Balamurali |
| Designation |
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| Affiliation |
|
| Address |
Manipal AcuNova KH Clinical Research Centre
IV floor, Sri Shirdi Sai Baba Cancer Hospital and ResearchCentre,
Not Applicable
N/A
576 104
India |
| Phone |
09916207559 |
| Fax |
08202571999 |
| Email |
balamurali.st@ecronacunova.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vinu Jose |
| Designation |
|
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
3W-146, Raheja Mindspace
Building No. 06
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
04067672946 |
| Fax |
04067672946 |
| Email |
vinu.jose@novartis.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Vinu Jose |
| Designation |
|
| Affiliation |
|
| Address |
3W-146, Raheja Mindspace
Building No. 06
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
04067672946 |
| Fax |
04067672946 |
| Email |
vinu.jose@novartis.com |
|
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Source of Monetary or Material Support
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| Novartis Healthcare Private Limited |
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Primary Sponsor
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| Name |
Novartis Healthcare Private Limited |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. S. T. Balamurali |
Manipal AcuNova KH Clinical Research Centre |
Sri Shirdi Sai Baba Cancer Hospital and Research Centre,IV floor-576104
|
08202922671
08202571999
balamurali.st@ecronacunova.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
This is a study in healthy subjects.
AEB071 is developed for prevention of solid organ transplantation and psoriasis.
, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
AEB071 capsule |
Single dose administration |
| Intervention |
AEB071 Coated tablet |
Single dose administration |
|
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
|
| Details |
Health volunteers of either gender between 18 to 45 years.
Women should be postmenopausal or surgically sterialized
Males should be using contraception
|
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| ExclusionCriteria |
| Details |
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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| To determine the relative bioavailability of AEB071 from a coated tablet versus an immediate-release capsule |
NIL |
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Secondary Outcome
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| Outcome |
TimePoints |
| To assess the safety and tolerability of AEB071 after single-dose administrations
|
NIL |
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Target Sample Size
|
Total Sample Size="16"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 1/ Phase 2 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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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. |