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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02446483
• Date of registration: 14/05/2015
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: 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
• Scientific title: 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
• Date of first enrolment: March 19, 2014
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02446483
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Egypt

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Diseases

Intervention(s)

Drug: Idiazole 20mg DR tabs

Drug: PARIET 20 mg DR tabs

Primary Outcome(s)

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) [Time Frame: 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.]

Mean Maximal Measured Plasma Concentration (Cmax) After a Single Dose [Time Frame: 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(s)

Time of the Maximum Plasma Concentration (T-max) and Terminal Half-life (T-half) [Time Frame: 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 [Time Frame: 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 ID(s)

201527

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 14/06/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02446483