Last updated: 11/03/2018 21:42:39

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

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GSK study ID
201527
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Clinicaltrials.gov ID
NCT02446483
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Mean maximal measured plasma concentration (Cmax) after a single dose

Timeframe: 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)

Timeframe: 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:

Time of the maximum plasma concentration (T-max) and Terminal half-life (T-half)

Timeframe: 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

Timeframe: 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

Interventions:
Drug: Idiazole 20mg DR tabs
Drug: PARIET 20 mg DR tabs
Enrollment:
60
Observational study model:
Not applicable
Primary completion date:
2014-26-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Gastrointestinal Diseases
Product
rabeprazole
Collaborators
Not applicable
Study date(s)
March 2014 to March 2014
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
  • 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).
  • Subjects with known allergy to the products tested.
  • Subjects whose values of BMI were outside the accepted normal ranges.
Inclusion and 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.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Cairo, Egypt
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
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Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2014-26-03
Actual study completion date
2014-26-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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