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
Sponsor study identifier
interventional
40
1 country
1
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2005
Actual (reported)Study Completion
April 2005
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2005
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
April 2005
Actual (reported)April 2005
Actual (reported)March 25, 2013
Actual (reported)March 28, 2013
Actual (reported)Pharmacodynamics of mean pH and percentage of time pH
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
ilaprazole and esomeprazole plasma concentration data and pharmacokinetic parameter estimates were tabulated and descriptive statistics computed
for 24 hours dosing of Ilaprazole
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.
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.
MDS Pharma Services
Québec, Canada
Gaetano Morelli, MD
MDS Pharma Services
40 participants (actual enrollment reported by the registry).
First Submitted
March 25, 2013
First Posted
March 28, 2013
Study Start
February 2005
Date type not reportedThis date has not been verified as actual or estimated.
Granisetron 1 mg Tablets, Non-fasting
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
April 2005
Actual (reported)Study Completion
April 2005
Actual (reported)Last Updated
March 28, 2013
Record last verified: 2005-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: