Study of Genetic effects of the drug Ilaprazole in healthy people

Pharmacogenomic influence of CYP2C19 genotype on Ilaprazole pharmacokinetics in Healthy South Asian population: A Single-Arm,Open-Label Study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/12/099533

Enrollment

Registered

2025-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ilaprazole: Ilaprazole,10mg oral, single dose for one day Control Intervention1: Nil: Nil

Eligibility

Inclusion criteria

Inclusion criteria: 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/m , 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To assess the pharmacokinetic parameters (Cmax, Tmax, AUC, Clearance, and t ) of Ilaprazole among different CYP2C19 metabolizer phenotypes in healthy South Asian volunteersTimepoint: Serial blood sampling: pre dose, 1st hr, 2nd hr,4th hr, 6th hr, 10th hr and 12th hr and 24th hr	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactMr Giridharan G R

SRM Institute of Science and Technology, Kattankulathur.

melving@srmist.edu.in9080281508

Outcome results