A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Diseases

Treatments: Drug: Idiazole 20mg DR tabs; Drug: PARIET 20 mg DR tabs

Study type: Interventional

Funder types: Industry

Identifiers

NCT02446483

201527

Details and patient eligibility

About

This is an open-label, randomized, single dose, two-sequence, two-period crossover study, separated by 7 days washout interval from the first study drug administration.

In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of each to healthy adults under fasting conditions, will be investigated by determining the 90% confidence limits for the log-transformed ratio (Test product / Reference product) for the bioequivalence parameters. The influence of sequence, product and period effect will be tested by analysis of variance (ANOVA).

In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will be done and the volume of blood will not exceed 300 milliliters (mL) for the study.

PARIET is a registered trademark of EISAI Co. Limited.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or female, age 18 to 55 years, inclusive.
• Body weight within 10 percent of normal range according to the accepted normal values for body mass index (BMI).
• Medical demographics without evidence of clinically significant deviation from normal medical condition.
• Results of clinical laboratory test are within the normal range or with a deviation that is not considered clinically significant by principal investigator.
• Subject does not have allergy to the drugs under investigation.

Exclusion criteria

• Subjects with known allergy to the products tested.
• Subjects whose values of BMI were outside the accepted normal ranges.
• Female subjects who were pregnant, nursing or taking birth control pills.
• Medical demographics with evidence of clinically significant deviation from normal medical condition.
• Results of laboratory tests which are clinically significant.
• Acute infection within one week preceding first study drug administration.
• History of drug or alcohol abuse.
• Subject does not agree not to take any prescription or non-prescription drugs within two weeks before first study drug administration and until the end of the study.
• Subject is on a special diet (for example subject is vegetarian).
• Subject does not agree not to consume any beverages or foods containing methyl-xanthenes e.g. caffeine (coffee, tea, cola, chocolate etc.) 48 hours prior to the study administration of either study period until donating the last sample in each respective period.
• Subject does not agree not to consume any beverages or foods containing grapefruit 7 days prior to first study drug administration until the end of the study.
• Subject has a history of severe diseases which have direct impact on the study. Participation in a bioequivalence study or in a clinical study within the last 6 weeks before first study drug administration.
• Subject intends to be hospitalized within 6 weeks after first study drug administration.
• Subjects who, through completion of this study, would have donated more than 500 mL of blood in 7 days, or 750 mL of blood in 30 days, 1000 mL in 90 days, 1250 mL in 120 days, 1500 mL in 180 days, 2000 mL in 270 days, 2500 mL of blood in 1 year.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A

Experimental group

Description:

Thirty subjects will receive a single oral dose of idiazole 20mg DR tabs under fasting 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 fasting condition in treatment period 2.

Treatment:

Drug: Idiazole 20mg DR tabs

Drug: PARIET 20 mg DR tabs

Group B

Experimental group

Description:

Thirty subjects will receive a single oral dose of PARIET 20 mg DR tabs under fasting 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 fasting condition in treatment period 2.

Treatment:

Drug: Idiazole 20mg DR tabs

Drug: PARIET 20 mg DR tabs