Overview
Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions
Status:
Completed
Completed
Trial end date:
2014-03-30
2014-03-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
GlaxoSmithKlineTreatments:
Rabeprazole
Criteria
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
milliliter (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.