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CTRI Number  CTRI/2025/12/099533 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 17/12/2025
Post Graduate Thesis  Yes 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Study of Genetic effects of the drug Ilaprazole in healthy people 
Scientific Title of Study   Pharmacogenomic influence of CYP2C19 genotype on Ilaprazole pharmacokinetics in Healthy South Asian population: A Single-Arm,Open-Label Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyadharshini A 
Designation  Assistant Professor 
Affiliation  SRM Institute of Science and Technology, Kattankulathur. 
Address  Department of pharmacy practice, SRM college of pharmacy, SRM Institute of science and technology, Kattankulathur, Chengalpattu district, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9787402050  
Fax    
Email  priyadha@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Melvin George 
Designation  Head and Professor of CCP and CCTR 
Affiliation  SRM Institute of Science and Technology, Kattankulathur. 
Address  SRM Medical College and Hospital and Research Center , SRM Institute of science and technology, kattankulathur, Chengalpattu district, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9080281508  
Fax    
Email  melving@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Mr Giridharan G R  
Designation  Student 
Affiliation  SRM Institute of Science and Technology, Kattankulathur. 
Address  Department of pharmacy practice, SRM College of Pharmacy, SRM Institute of science and technology, kattankulathur, Chengalpattu district, Tamil Nadu, India

Kancheepuram
TAMIL NADU
603203
India 
Phone  9080076198  
Fax    
Email  dharan8771@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Center, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu-603203, India 
 
Primary Sponsor  
Name  SRM college of pharmacy, SRM Institute of Technology, Kattankulathur, Chengalpattu 
Address  SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District, Tamil Nadu-603203, India 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyadharshini A  Clinical Trials and Research Unit - Metabolic Ward, SRM Medical College Hospital and Research Centre  SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU 		 9787402050

priyadha@srmist.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy male volunteers aged 18-45 years, body weight 50 kg, BMI between 18.50 and 24.99 Kg/m².  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ilaprazole  Ilaprazole,10mg oral, single dose for one day  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  Body weight more than 50 kg, Willing to provide informed written consent and comply with study
Requirements, Capable of effective communication, Non-smokers or individuals who smoke fewer than 5 cigarettes per day, Teetotalers or individuals consuming less than 60 mL of high alcohol
content liquor or 120 mL of low alcohol content liquor, BMI between 18.50 and 24.99 Kg/m², Healthy based on personal history, medical history, and clinical examination, Vital parameters within the following BP: 100-139 mmHg (systolic) and 60-89 mmHg (diastolic), Pulse rate: 60-100 bpm, Temperature: 97.8°F to 99.0°F, Respiratory rate: 14-22/min, Negative tests for HIV 1, Hepatitis B, Hepatitis C, and Syphilis.
 
 
ExclusionCriteria 
Details  Inability to understand informed consent,history of major surgical procedures in the past 3 months.
History of diabetes mellitus, tuberculosis, systemic hypertension, or
significant disorders in major organ systems (cardiac, gastrointestinal,
respiratory, hepatic, renal, endocrine, neurological, metabolic, psychiatric,
or hematological systems).
History of dysphagia or hypersensitivity to the study drugs, History of allergy to food or vegetables, Present or past history of drug abuse.
Prior use of drugs that could modify the pharmacokinetics or dynamics of
the study medication.
Consumption of grapefruit or its products within 48 hours prior to the start of the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the pharmacokinetic parameters (Cmax, Tmax, AUC, Clearance, and t½) of
Ilaprazole among different CYP2C19 metabolizer phenotypes in healthy South Asian volunteers  		 Serial blood sampling: pre dose, 1st hr, 2nd hr,4th hr, 6th hr, 10th hr and 12th hr and 24th hr 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   05/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Healthy south asian volunteers are recruited with informed consent.Then blood samples will be collected to perform CYP2C19 genotyping where participants are then stratified into groups as poor and extensive metabolizers of CYP2C19.Then eligible participants are then narrowed down with their general examination laboratory tests. And on the day of study necessary instructions for the study will be instructed and a single dose of the study drug will be administered in early morning on empty stomach for better absorption. After administration serial blood samples will be collected (eg: pre-dose,1h, 2h, 3h, 6h, 10h, 12h, 24h) accordingly and further samples will be processed and bioanalysis will be done by using LC-MS/MS to determine the drug concentrations in the blood and assess the  PK parameters to compare between the categorized genotype groups. Vital signs and Adverse Drug Events will be monitored on the day of the study. 
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