A Study to Evaluate the Effect on 24-hour, Intragastric pH of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40 mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets
Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: E3810 (Drug); Aciphex (rabeprazole) (Drug); Nexium (esomeprazole) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Eisai Inc. Official(s) and/or principal investigator(s): Philip Miner, Principal Investigator, Affiliation: Oklahoma Foundation for Digestive Research, 1000 N. Lincoln, Suite 210, Oklahoma City, OK 73104 USA
Summary
This will be a randomized, open-label, single-center, 3-way crossover study in healthy
subjects who are confirmed to be Helicobacter pylori (H. pylori)-negative. The study will
consist of 3 study periods separated by a washout period of at least 7 days. Subjects will
receive study drugs once daily for 5 days. Barring any safety concerns, subjects will be
discharged from the study on Day 6 of Period 3 after completion of discharge procedures.
Clinical Details
Official title: A Randomized, Open-Label, Three-Way Crossover Study to Evaluate the Effect on 24-hour, Intragastric pH Following Daily Oral Dose Administration of RAB ER 50-mg Capsules Compared With Esomeprazole (Nexium) 40-mg Capsules and Rabeprazole (Aciphex) 20-mg Tablets to H. Pylori-Negative Healthy Subjects in a 5-day Treatment Regimen
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of time that intragastric pH remains >4
Secondary outcome: Percentage of day- and night-time periods with intragastric pH >4Number and duration of nocturnal acid breakthrough (NAB) episodes Proportion of subjects with nocturnal acid breakthrough (NAB) episodes
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Key inclusion:
- Healthy male and female subjects, including women of child-bearing potential, aged 18
to 55 years, inclusive
- Subjects who are able to tolerate the insertion and placement of a pH probe on 2
occasions per study period (Day - 1 and Day 5)
Key Exclusion:
- Subjects who are H. pylori-positive
- Subjects who have a history of any gastrointestinal disorder or surgery likely to
influence drug absorption (e. g., history of gastric resection)
- Known hypersensitivity to rabeprazole, esomeprazole, or related compounds or any
ingredient in the formulations
- Other standard clinical pharmacology exclusion criteria for healthy volunteers
Locations and Contacts
Oklahoma Foundation for Digestive Research, Oklahoma City, Oklahoma 73104, United States
Additional Information
Starting date: July 2010
Last updated: October 31, 2013
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