Bioequivalence Study of Raperazole 20mg DR Tabs and PARIET® 20 mg DR Tabs Under Fed Conditions

NCT02605395 | Completed Phase 4 Results

• 1 other identifier: 201528
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Diseases

Keywords

Bioequivalence; Fed condition; PARIET 20 mg; IDIAZOLE 20mg; Rabeprazole

Outcome Measures

Primary Outcomes (3)

• Maximal Measured Plasma Concentration (Cmax) of Rabeprazole

  Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. The Cmax was computed directly from measured data.

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

• Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC [0-t]) of Rabeprazole

  Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods. AUC (0-t) was calculated from measured data points from time of administration to time of last quantifiable concentration (Clast) by the linear trapezoidal rule.

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

• Mean Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC [0 to Infinity]) of Rabeprazole

  Blood samples were collected for pharmacokinetic analyses in each period at specified time points. Pharmacokinetic parameters of rabeprazole were estimated using standard non-compartmental methods.

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Secondary Outcomes (3)

• Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

• Mean Apparent First-order Elimination or Terminal Rate Constant (Ke) of Rabeprazole

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

• Mean Terminal Half Life (t1/2) of Rabeprazole

  Pre-dose and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 12, 14 and 24 hours post-dose in period 1 and 2

Study Arms (2)

Group A-Idiazole then Pariet

EXPERIMENTAL

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.

Drug: IDIAZOLE 20mg DR tabs; Drug: PARIET 20 mg DR tabs

Group B-Pariet then Idiazole

EXPERIMENTAL

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.

Drug: IDIAZOLE 20mg DR tabs; Drug: PARIET 20 mg DR tabs

Interventions

IDIAZOLE 20mg DR tabs DRUG

IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Group A-Idiazole then Pariet; Group B-Pariet then Idiazole

PARIET 20 mg DR tabs DRUG

PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.

Group A-Idiazole then Pariet; Group B-Pariet then Idiazole

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 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.

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: November 16, 2015
• Study Start: March 22, 2014
• Primary Completion: March 30, 2014
• Study Completion: March 30, 2014
• Last Updated: October 1, 2018
• Results First Posted: October 1, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)