- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01820143
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety
March 25, 2013 updated by: Il-Yang Pharm. Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Québec, Canada
- MDS Pharma Services
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- The subject was between 18 and 55 years, inclusive, and was generally in good health.
- 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.
- 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.
- Subject had a negative breath test result for H pylori prior to enrollment.
- 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.
- Subject was in general good health as evidenced by a medical history, a complete physical examination, and ECG without clinically significant abnormalities.
Exclusion Criteria:
- 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment sequence ADBC
Regimen 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.
|
|
Experimental: Treatment sequence BACD
Regimen 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.
|
|
Experimental: Treatment sequence CBDA
Regimen 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.
|
|
Experimental: Treatment sequence DCAB
Regimen 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamics of mean pH and percentage of time pH
Time Frame: for 24 hours dosing of Ilaprazole
|
For each regimen and day, mean pH and percentage of time pH exceeded 3, 4, 5, and 6 were tabulated and descriptive statistics were provided for 24-hour postdose intervals and each of the following intervals of time relative to dosing: 0 to 4 hours, >4 to 9 hours, >9 to 12 hours, >12 to 16 hours, and >16 to 24 hours.
|
for 24 hours dosing of Ilaprazole
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ilaprazole and esomeprazole plasma concentration data and pharmacokinetic parameter estimates were tabulated and descriptive statistics computed
Time Frame: for 24 hours dosing of Ilaprazole
|
The assessments of dose proportionality for ilaprazole regimens were performed via 90% confidence intervals for the ratio of the central values obtained within the framework of the ANOVA on natural logarithms of dose-normalized Cmax, AUCt, and AUC
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for 24 hours dosing of Ilaprazole
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2005
Primary Completion (Actual)
April 1, 2005
Study Completion (Actual)
April 1, 2005
Study Registration Dates
First Submitted
March 25, 2013
First Submitted That Met QC Criteria
March 25, 2013
First Posted (Estimate)
March 28, 2013
Study Record Updates
Last Update Posted (Estimate)
March 28, 2013
Last Update Submitted That Met QC Criteria
March 25, 2013
Last Verified
June 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z-P104-099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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