Bioequivalence Study of Raperazole 20mg DR Tabs and PARIE... | NCT02605395

NCT02605395

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Mean Time to the Maximum Plasma Concentration (Tmax) of Rabeprazole	Blood samples were collected for pharmacokinetic analysis in each period at specified time points. Pharmacokinetic parameters of Rabeprazole were estimated using standard non-compartmental methods. Tmax was computed directly from the 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

Eligibility Module

Eligibility 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 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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
201528	Clinical Study Report	View IPD

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Pariet 20 mg Followed by Idiazole 20 mg	Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablet in period 1 followed by Idiazole 20 mg gastro-resistant tablets in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.
FG001	Idiazole 20 mg Followed by Pariet 20 mg	Eligible participants received a single oral dose of Idiazole 20 mg gastro-resistant tablets in period 1 followed by Pariet 20 mg enteric coated tablet in period 2. Both the treatments were administered under fed condition. Treatment period 1 and period 2 were separated by a 7 days washout period.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	All Study Participants	Eligible participants received a single oral dose of Pariet 20 mg enteric coated tablets or Idiazole 20 mg gastro-resistant tablets under fed condition in any of the 2 treatment periods. There was a 7 days washout interval between two study drug administration.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All subject population comprised of all participants who received at least one dose of study medication.

Posted

Mean

Standard Deviation

Nanograms per milliliter

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

ID	Title	Description
OG000	Idiazole 20 mg	Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Idiazole 20 mg	Eligible participants received a single oral dose of Idiazole 20 mg enteric coated tablets under fed condition in treatment period 1 or 2.

ID	Term
D053799	2-Pyridinylmethylsulfinylbenzimidazoles
D013454	Sulfoxides
D013457	Sulfur Compounds
D009930	Organic Chemicals