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

NCT02446483 | Completed Phase 4 Results

• 1 other identifier: 201527
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Diseases

Keywords

Idiazole 20mg; PARIET 20 mg; Rabeprazole; bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half)

  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

  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

Study Arms (2)

Group A

EXPERIMENTAL

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; Drug: PARIET 20 mg DR tabs

Group B

EXPERIMENTAL

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; Drug: PARIET 20 mg DR tabs

Interventions

Idiazole 20mg DR tabs DRUG

Delayed release tablets containing 20 mg of rabeprazole

Group A; Group B

PARIET 20 mg DR tabs DRUG

Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Cairo, Egypt

Location

Related 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.

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Rabeprazole

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: March 19, 2014
• Primary Completion: March 26, 2014
• Study Completion: March 26, 2014
• Last Updated: November 17, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)