Status:
COMPLETED
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety
Lead Sponsor:
Il-Yang Pharm. Co., Ltd.
Conditions:
Healthy
Pharmacokinetics
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 (Q...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01820143
Start Date
February 1 2005
End Date
April 1 2005
Last Update
March 28 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MDS Pharma Services
Québec, Canada