| CTRI Number |
CTRI/2009/091/000723 [Registered on: 23/09/2009] |
| 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 |
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Public Title of Study
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A clinical trial to evaluate and compare the blood levels of aliskiren mini-tablets with aliskiren market tablet under fasted condition and futher evaluate aliskiren mini-tablets under fed condition in healthy subjects |
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Scientific Title of Study
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An open label, randomized, three period, single-dose, crossover study to determine the bioavailability of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition and to evaluate the effect of food on the pharmacokinetics of 300 mg aliskiren minitablets in healthy subjects |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| CSPP100A2109 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr.Srinivas Shenoy.B |
| Designation |
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| Affiliation |
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| Address |
Manipal AcuNova KMC Clinical Pharmacology Unit,
V floor, MCODS Building, KMC Hospital
Not Applicable
N/A
575 001
India |
| Phone |
+91-824-6621113 |
| Fax |
+91-824-2425092 |
| Email |
srinivas.s@ecronacunova.com |
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Details of Contact Person
Scientific Query
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| Name |
karan Rajesh |
| Designation |
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| Affiliation |
Novartis Healthcare Pvt. Ltd. |
| Address |
Novartis Healthcare Pvt. Ltd.
Hitech City, Madhapur
Hyderabad
ANDHRA PRADESH
500 081
India |
| Phone |
+91 40 67672945, +919160089988 |
| Fax |
+91 40 67671300 |
| Email |
rajesh.karan@novartis.com |
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Details of Contact Person
Public Query
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| Name |
Siva Kumar Vaidyanathan |
| Designation |
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| Affiliation |
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| Address |
3W 140, Raheja IT Park,
Mind Space - Bld # 6,
Hyderabad
ANDHRA PRADESH
500081
India |
| Phone |
+91 40 6767 2940, +91 9908922337 |
| Fax |
+91 40 6767 1300 |
| Email |
sivakumar.vaidyanathan@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. Shalini S Rao, Senior Clinical Investigator |
Manipal AcuNova KMC Clinical Pharmacology Unit, |
V floor, MCODS Building, KMC Hospital,Attavar, -575 001
Bangalore
KARNATAKA |
+91-824-6621100, Ext: 104
+91-824-2425092
shalini.rao@ecronacunova.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MU Ethics Sub Commitee (BA & BE), Manipal, 576104, India |
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 Healthy Volunteer study, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Aliskiren mini tablets |
300 mg (1 Mini-Tablet = 3.125mg, 96 x 3.125= 300 mg)
96 mini-tablets will be administred as a single dose which is equivalent to 300 mg |
| Comparator Agent |
Aliskiren Tablet |
300 mg |
| Comparator Agent |
Nil |
Nil |
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Inclusion Criteria
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| Age From |
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| Age To |
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| Gender |
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| Details |
Healthy male and female subjects ( women of non-child bearing
potential) |
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| ExclusionCriteria |
| Details |
Female subjects of child bearing potential. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study. |
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Method of Generating Random Sequence
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Not Applicable |
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Method of Concealment
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Not Applicable |
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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 bioavailability of a single oral dose of 300 mg aliskiren mini-tablets relative to the 300 mg aliskiren market tablet under fasted condition in healthy subjects
To evaluate the effect of food on the pharmacokinetics of a single oral dose of 300 mg aliskiren mini-tablets in healthy subjects |
Single Dose Of SPP100 Administration
Under Fasting Or Fed Condition Followed
By PK Sample Collection Till Day 8
(Except On Day 6) |
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Secondary Outcome
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| Outcome |
TimePoints |
| To evaluate the safety and tolerability of a single oral dose of 300 mg aliskiren mini-tablets administered with or without meal and a single oral dose of 300 mg aliskiren market tablet in healthy subjects without meal, respectively. |
Number Of AEs From First Dosing To End Of Study Evaluation And Number Of SAEs From Date Of ICF To 4weeks After Last Dose Administration. Safety assessments will also include vital signs, blood pressure and pulse rate) standard clinical laboratory evaluations. Blood pressure, pulse rate: screening*, each baseline*, pre- dose* and 2, 4, 12 and 24* hours post dose, end of study* Note: measurements are supine, or supine and after 3 min standing if indicated by an *asterisk) Hematology; Blood chemistry; Urinalysis: screening, each baseline, end of study |
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Target Sample Size
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Total Sample Size="69"
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 |
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Date of First Enrollment (India)
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Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/12/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="0"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
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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
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