A Bioequivalence Study of Rabeprazole From Idiazole 20mg DR Tabs (GSK, Egypt) and PARIET 20 mg DR Tabs (JANSSEN, EGYPT)

NCT02477306 | Completed Phase 1

• 1 other identifier: GRC1/14/516GSKRABFST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• Maximal measured plasma concentration (Cmax)

  Serial blood samples for determination of study drug will be collected pre-dose and at 0.00, 0.50, 1.00, 1.50, 2.00, 2.33, 2.67, 3.00, 3.33, 3.67, 4.00, 4.33, 4.67, 5.0, 5.33, 5.67, 6.00, 8.00, 12.0 and 14.0 hours post dose, relative to dosing on Day 1 in each cross over period.

  Up to 14 hours post dose in each treatment period

• Area under the plasma concentration-time curve from time zero to the last measurable concentration (t) (AUC [0 to t])

  (AUC \[0 to t\]) will be calculated by the linear trapezoidal method.

  Up to 14 hours post dose in each treatment period

• Area Under the plasma concentration-time curve from time zero to infinity (AUC [0 to infinity])

  AUC (0 to infinity) will be calculated as the sum of the AUC (0 to t) plus the ratio of the last measurable plasma concentration to the elimination rate constant

  Up to 14 hours post dose in each treatment period

Secondary Outcomes (3)

• Time of the maximum plasma concentration (tmax)

  Up to 14 hours post dose in each treatment period

• Apparent first-order elimination or terminal rate constant (K¬e)

  Up to 14 hours post dose in each treatment period

• Terminal half life (t1/2e)

  Up to 14 hours post dose in each treatment period

Study Arms (1)

Study group

EXPERIMENTAL

60 subjects will receive a single oral dose of idiazole 20mg DR tabs under fasting condition in one period. And the subjects will receive a single dose of PARIET 20 mg DR tabs under fasting condition in the second period. A 7 days washout interval is in between the 2 periods

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

Study group

PARIET 20 mg DR tabs DRUG

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

Study group

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 15% 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 are 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

• Genuine Research Center, Egypt: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Genuine Research Center GRC

Cairo, Egypt

Location

Related Links

• International conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline Q2B. Guidelines for Validation of Analytical Procedures: Methodology. November, 1996

MeSH Terms

Interventions

Rabeprazole

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

Study Officials

• Ahmed Elshafeey, Ph.D. Pharma

  Genuine Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 22, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 22, 2015

Record last verified: 2015-06

Locations

EG (1)