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

Comparative Randomized, Single Dose, Two-way Crossover Open-label Study to Determine the Bioequivalence of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt)and PARIET 20 mg DR Tabs (JANSSEN, EGYPT) After a Single Oral Dose Administration of Each to Healthy Adults Under Fasting Conditions

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Diseases
• Intervention / Treatment: Drug: Idiazole 20mg DR tabs; Drug: PARIET 20 mg DR tabs

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	Drug: Idiazole 20mg DR tabs; Delayed release tablets containing 20 mg of rabeprazole; Drug: PARIET 20 mg DR tabs; Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Experimental: Group B; 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.	Drug: Idiazole 20mg DR tabs; Delayed release tablets containing 20 mg of rabeprazole; Drug: PARIET 20 mg DR tabs; Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose	Plasma samples for pharmacokinetic (PK) analysis were drawn at indicated time points of each treatment period. Cmax was defined as maximal measured plasma concentration over the time span specified. Values were reported as Least Squares Geometric Means with respective Geometric Coefficient of Variation (% CV).	Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) and Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-infinity)	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. AUC0-t was calculated by the linear trapezoidal method. AUC0-infinity was calculated as the sum of the AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant, where first-order elimination or terminal rate constant was calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations. Values were reported as Least Squares Geometric Means with respective % CV.	Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half)	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with b obtained as the slope of the linear regression of the logarithmically transformed plasma concentrations versus time in the terminal period of the plasma curve.	Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period.
Apparent First-order Elimination or Terminal Rate Constant	Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares regression analysis using the last three (or more) non-zero plasma concentrations.	Pre-dose (0.00) and 0.50, 1.00, 1.50, 2.00, 2.33, 2.66, 3.00, 3.33, 3.66, 4.00, 4.33, 4.66, 5.00, 5.33, 5.66, 6.00, 8.00, 12.00 and 14.00 h post-dose in each treatment period

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2014
• Primary Completion (Actual): March 26, 2014
• Study Completion (Actual): March 26, 2014

Study Registration Dates

• First Submitted: May 14, 2015
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: October 17, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: bioequivalence; Rabeprazole; PARIET 20 mg; Idiazole 20mg
• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: 201527

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Clinical Study Report
   Information identifier: 201527
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 201527
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Study Protocol
   Information identifier: 201527
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 201527
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 201527
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register