Gastrointestinal DiseasesPhase 4NCT02446483

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

A Phase 4 study testing Idiazole 20mg DR tabs and PARIET 20 mg DR tabs in people with Gastrointestinal Diseases, run by GlaxoSmithKline at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Gastrointestinal Diseases
What is being tested?: Idiazole 20mg DR tabs and PARIET 20 mg DR tabs
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 19 Mar 2014to 26 Mar 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 14Show fewer

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 locations and contacts

1 site in 1 country.

Egypt1 site

GSK Investigational Site
Cairo

Other trials in Egypt

About this study

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

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
Being tested: Idiazole 20mg DR tabs, PARIET 20 mg DR tabs
Keywords: Idiazole 20mg, PARIET 20 mg, Rabeprazole, bioequivalence
Medical subject headings: Gastrointestinal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Idiazole 20mg DR tabsDrug
Delayed release tablets containing 20 mg of rabeprazole
PARIET 20 mg DR tabsDrug
Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.

Study groups in NCT02446483
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Idiazole 20mg DR tabs; Drug: PARIET 20 mg DR tabs

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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)
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. If the maximum value occurs at more than one point T-max was defined as the first time point with this value. The elimination or terminal half-life was calculated by dividing 0.693 (natural logarithm of 2) with b obtained as the slope of the linear regression of the logarithmically transformed plasma concentrations versus time in the terminal period of the plasma curve.
Measured: 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
Plasma samples for PK analysis were drawn at indicated time points of each treatment period. Apparent first-order elimination or terminal rate constant 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.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Mar 201426 Mar 2014

First posted18 May 2015 (estimated)
Study start19 Mar 2014
Primary completion26 Mar 2014
Study completion26 Mar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02446483
Sponsor's protocol ID: 201527
Status last verified: Oct 2017
First submitted: 14 May 2015
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02446483
Acronym / sponsor ID: 201527
Conditions: Gastrointestinal Diseases
Keywords: Idiazole 20mg, PARIET 20 mg, Rabeprazole, bioequivalence
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Mar 2014 (actual)
Primary completion: 26 Mar 2014 (actual)
Study completion: 26 Mar 2014 (actual)
First posted: 18 May 2015 (estimated)
Results: Posted 14 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

PARIET is a registered trademark of EISAI Co. Limited.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group A	Experimental	Drug: Idiazole 20mg DR tabs, Drug: PARIET 20 mg DR tabsThirty 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.
Group B	Experimental	Drug: Idiazole 20mg DR tabs, Drug: PARIET 20 mg DR tabsThirty 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.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Idiazole 20mg DR tabsDelayed release tablets containing 20 mg of rabeprazole	Drug	Group A, Group B
PARIET 20 mg DR tabsOrally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.	Drug	Group A, Group B

Primary outcome

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.
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).
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.
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.

2 secondary outcomes

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

Results and safety

Results posted to the registry on 14 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A-rabeprazole 20mg,Then Treatment B-rabeprazole 20mg	30	30
Treatment B-rabeprazole 20mg,Then Treatment A-rabeprazole 20mg	30	30

Primary outcome: 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.. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per mL (ng/mL)

Measure	Treatment A- Rabeprazole 20 mg n = 60	Treatment B- Rabeprazole 20 mg n = 60
Value	543.78 (35.67)	530.34 (32.98)

Treatment A- Rabeprazole 20 mg vs Treatment B- Rabeprazole 20 mg: Point Estimate Percent: 101.32 (90% CI 95.81 to 107.15)

Population analysed: All subject population comprised of all participants who were crossed over and completed the balance design, were included in the calculation.

Primary outcome: 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)

Measure	Treatment A- Rabeprazole 20 mg n = 60	Treatment B- Rabeprazole 20 mg n = 60
AUC0-t	916.07 (43.30)	922.52 (40.97)
AUC0-infinity	971.38 (41.98)	959.78 (42.21)

Treatment A- Rabeprazole 20 mg vs Treatment B- Rabeprazole 20 mg: Point Estimate Percent: 98.71 (90% CI 92.54 to 105.28)
Treatment A- Rabeprazole 20 mg vs Treatment B- Rabeprazole 20 mg: Point Estimate Percent: 98.05 (90% CI 91.81 to 104.71)

Population analysed: All subject population. Only those participants available at the specified time points were analyzed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AE) and serious adverse events (SAE) were reported through out the study (up to 11 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A- Rabeprazole 20 mg	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Treatment B- Rabeprazole 20 mg	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Idiazole 20mg DR tabs and PARIET 20 mg DR tabs in people with Gastrointestinal Diseases, run by GlaxoSmithKline at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02446483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.