Completed
A Phase 1, Randomized, Open-Label, Four-Period Crossover, Multiple-Dose, Single-Center Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety Following Administration of Oral Doses of 10, 20 and 40 mg of Ilaprazole and 40 mg of Esomeprazole in Healthy Subjects
What is being tested
Ilaprazole
+ Esomeprazole
+ Ilaprazole
Drug
Who is being recruted
From 18 to 55 Years
+8 Eligibility Criteria
How is the trial designed
Phase 1
Interventional
Study Start: February 2005
Summary
Principal SponsorIl-Yang Pharm. Co., Ltd.
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2005
Actual date on which the first participant was enrolled.The objectives of this study were (a) to evaluate the pharmacokinetics and to evaluate and compare the pharmacodynamics of ilaprazole and esomeprazole following a single dose (Day 1) and once daily (QD) administration for 5 consecutive days each of 10-mg, 20-mg, and 40-mg ilaprazole tablets and 40-mg esomeprazole tablets; (b) to evaluate the safety of 10-mg, 20-mg, and 40-mg ilaprazole tablets following QD oral administration for 5 consecutive days; and (c) to characterize the plasma gastrin concentration profile on Day 1 and Day 5 following QD oral administration of 10-mg, 20-mg, and 40-mg ilaprazole and 40-mg esomeprazole tablets for 5 consecutive days.
Principal SponsorIl-Yang Pharm. Co., Ltd.
Last updated: March 28, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
At the Screening Visit, subject had a body mass index (BMI) within the range of 18 to 30 kg/m2, as determined by the following calculation
Female subject was using, and agreed to continue the use of, a double-barrier method of birth control. Oral, patch, implants, or injectable contraceptives were accepted as 1 method if the subject had been taking them for greater than 2 months at the Screening Visit. Subjects who had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy for a minimum of 6 months, or surgical sterilization of partner (vasectomy for 6 months minimum), or were postmenopausal (defined as the absence of menses for 2 years or the absence of menses for 12 months and follicle-stimulating hormone [FSH] level of > 40 IU/L) did not require the use of birth control
Pregnancy test results for all females were negative in order to enter and remain in the study. A serum pregnancy test was performed on all females at Screening, Day -1 of each period, and Day 6 of Period 4 only, or if a subject prematurely discontinued. Results must have been negative in order for study drug to be administered
Prior to any study-specific procedures being performed, the subject voluntarily signed the approved informed consent/PIPEDA authorization form after having it fully explained and all questions answered
Show More Criteria
1 exclusion criteria prevent from participating
Subject had current evidence of cardiovascular, central nervous system, hepatic, hematopoietic, renal, or metabolic dysfunction; serious allergy, asthma, history of significant sensitivity to any drug; or lactose intolerance that would contraindicate taking ilaprazole or esomeprazole or would interfere with the conduct of the study
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
4 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Group II
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Group III
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Group IV
ExperimentalRegimen A: 10 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen B: 20 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen C: 40 mg of ilaprazole administered QD for 5 days with 240 mL of water.
Regimen D: 40 mg of esomeprazole administered QD for 5 days with 240 mL of water.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center