Phase 2
Completed N=24
A Clinical Pharmacological Study of Rabeprazole Sodium in Japanese Healthy Adult Male Volunteers (Study E3810)
Healthy
Source: ClinicalTrials.gov NCT01202071 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcomePrimary: Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration — 45.63; 57.81; 61.36; 71.52 Percentage of Time in a 24 Hour Period
Summary
The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration |
45.63; 57.81; 61.36; 71.52; 62.51; 71.83 | — |
| SECONDARY Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) |
137.7; 253.6; 520.0; 1007.6; 146.0; 382.8 | — |
| SECONDARY Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) |
215.5; 429.7; 866.9; 1807.2; 235.7; 539.1 | — |
Eligibility Criteria
Inclusion Criteria
- healthy adult Japanese male between the age of 20-40
- body mass index between 18.5-25
Exclusion Criteria
- clinically significant abnormal physical examination, vital signs or electrocardiogram
- use of any prescription medication, antacid, nutritional supplement, vitamin preparation, or herb-containing drug within the previous 4 weeks
- use of any non-prescription medication within the previous 1 week
- history of drug or alcohol abuse
Data sourced from ClinicalTrials.gov (NCT01202071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.