drugset / Trial / NCT01820143
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety
RandomizedCrossoverOpen-label
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 (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.
Timeline
- Start
- 2005-02
- Primary completion
- 2005-04
- Completion
- 2005-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Esomeprazole | Small molecule | 40 mg | Oral |
| Subject | Ilaprazole | Small molecule | 10 mg | Oral |
| Subject | Ilaprazole | Small molecule | 20 mg | Oral |
| Subject | Ilaprazole | Small molecule | 40 mg | Oral |
Indications
No indication recorded.