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OpenTrials
Completed

NCT Number: NCT01820143

Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

MDS Pharma Services

Québec, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ilaprazole

Drug

Esomeprazole

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Il-Yang Pharm. Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Mar 28, 2013
Registry last updated
Mar 28, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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