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A Pilot Cross-over Bioequivalence Study of E3810 for Healthy Japanese Male (Under Postprandial Condition)

2014-08-27 03:15:17 | BioPortfolio

Summary

The purpose of this study is to assess pharmacokinetics of rabeprazole under postprandial condition.

Description

The purpose of this study is to assess bioequivalence after single administration of the following 4 types of formulations: normal 10 mg rabeprazole tablet, Type 1, Type 2, and Type 3 granule formulations containing rabeprazole 10 mg.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

rabeprazole, rabeprazole, rabeprazole, rabeprazole

Status

Not yet recruiting

Source

Eisai Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:17-0400

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Medical and Biotech [MESH] Definitions

A 4-(3-methoxypropoxy)-3-methylpyridinyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.

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Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

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Process of evaluating the health of a patient and determining if they are healthy enough for surgery.

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