Conditions: Gastrointestinal Diseases
Keywords: Bioequivalence Fed condition PARIET 20 mg IDIAZOLE 20mg Rabeprazole
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 70
Healthy volunteers: yes

Brief summary:
This is an open-label, randomized, single dose, two-sequence, two-periods crossover study, separated by 7 days washout interval from the first Study Drug Administration. This study is conducted to determine the bioequivalence of Rabeprazole from IDIAZOLE 20mg Delayed-Release (DR) tablets (tabs) and PARIET 20 mg DR tabs after a single oral dose administration of each to healthy adults fed under conditions.

In Period 1, subjects will be randomized to either Idiazole 20mg DR tabs or PARIET 20 mg DR tabs. Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

PARIET is a registered trademark of EISAI Co. Limited.

Detailed description:

Arms:
arm 1: Subjects will receive a single oral dose of IDIAZOLE 20mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of PARIET 20 mg DR tabs under fed condition in treatment period 2. arm 2: Subjects will receive a single oral dose of PARIET 20 mg DR tabs under fed condition in treatment period 1 followed by 7 days washout interval from the first study drug administration. After the washout interval the subjects will receive a single dose of Idiazole 20mg DR tabs under fed condition in treatment period 2.

Interventions: intervention 1: IDIAZOLE 20mg DR tabs intervention 2: PARIET 20 mg DR tabs
Intervention descriptions: intervention 1: IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium. intervention 2: PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.

Protocol document: