A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers

January 21, 2013 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Relative Bioavailability of Rabeprazole Sodium Sprinkle Capsule Formulation Using Different Dosing Vehicles Following Single-dose Administration in Healthy Adult Subjects

The purpose of the study is to investigate the bioavailability (rate and extent of absorption) of rabeprazole sodium when a sprinkle capsule granule formulation of rabeprazole sodium is mixed with different dosing vehicles (food, others) and is administered to healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastro Esophageal Reflux Disease (GERD). GERD is a condition in which the esophagus (tube from throat to stomach) becomes irritated or inflamed because of acid backing up from the stomach.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (volunteer and investigator will know the name of the assigned treatment) single center study to evaluate the bioavailability (rate and extent of absorption) and safety of different dosing vehicles used to administer a pediatric formulation of rabeprazole sodium to healthy adult volunteers. A dosing vehicle is a food or liquid that is mixed with rabeprazole sodium for oral (by mouth) administration. Approximately 35 healthy adult volunteers will be enrolled and randomized (assigned by chance) to 1 of 5 possible treatment sequences to receive each of the following single-dose treatments: 1) the contents of rabeprazole sprinkle capsules mixed in a strawberry-flavored vehicle suspension (Treatment A), 2) the contents of rabeprazole sprinkle capsules sprinkled on 1 tablespoon of plain yogurt (Treatment B), 3) the contents of rabeprazole sprinkle capsules sprinkled on 1 tablespoon of applesauce (Treatment C), 4) the contents of rabeprazole sprinkle capsules mixed with 5 mL (1 teaspoon) of formula milk (Treatment D), and 5) the contents of rabeprazole sprinkle capsules mixed in a tablet vehicle suspension (Treatment E). Each volunteer will receive 5 single-dose treatments during the study (1 single-dose treatment during each treatment period). A period of at least 7 days will separate each treatment period. During each treatment period, volunteers will be required to stay overnight at the study center for 12 hours before study drug administration up to approximately 24 hours after study drug administration to have study procedures performed and blood samples collected to measure the concentration of rabeprazole and its thioether metabolite (a substance produced when rabeprazole is absorbed in the body). Volunteers will fast (withhold from eating food) for at least 10 hours before study drug administration and up to at least 4 hours after study drug administration. On dosing days, volunteers will not receive a morning meal but will be allowed to drink non-carbonated water for up to 2 hours before study drug administration. After dosing, a standard lunch, snack, and dinner will be provided to volunteers. Each volunteer will participate in the study for approximately 55 days and be monitored for safety during the study by evaluating adverse events reported and results from clinical laboratory tests, 12-lead electrocardiograms (ECGs), vital sign measurements, and physical examinations. On Day 1 of each treatment period, volunteers will be administered the contents from 2 capsules equivalent to 10 mg of rabeprazole sodium mixed with a strawberry-flavored vehicle reconstituted with water or a vehicle tablet reconstituted with water (Treatments A and E, respectively) or 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt or applesauce (Treatments B and C, respectively), or 10 mg rabeprazole sodium mixed with 5 mL of formula milk (Treatment D).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult volunteers with a body mass index (ie, the relationship between a person's height and weight) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Have normal blood pressure between 90 and 140 mmHg systolic and <=90 mmHg diastolic
  • Female volunteers must have a negative serum beta human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on the day before each treatment period
  • Female volunteers must be postmenopausal (no spontaneous menses for at least 2 years), surgically sterile, abstinent, or, if of childbearing potential and sexually active, be practicing an effective method of birth control before entry and throughout the study
  • Male volunteers must agree to use an adequate contraception method as deemed appropriate by the investigator

Exclusion Criteria:

  • Currently have, or have a history of clinically significant medical illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
  • Have a history of drug or alcohol abuse within the past 1 year or a history of clinically significant allergies, especially known hypersensitivity or intolerance to milk products
  • Have a history of smoking or use of nicotine-containing substances within the previous 2 months
  • Have had major or traumatic surgery within 12 weeks before screening or preplanned surgery or procedures that would interfere with the conduct of the study
  • known allergy to the study drug or any of the excipients of the formulation or known allergy to heparin or history of heparin-induced thrombocytopenia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment sequence AEBDC
Drug: Rabeprazole sodium: Treatment E
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Drug: Rabeprazole sodium: Treatment C
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Drug: Rabeprazole sodium: Treatment D
The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Drug: Rabeprazole sodium: Treatment A
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
Drug: Rabeprazole sodium: Treatment B
The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
Experimental: Treatment sequence BACED
Drug: Rabeprazole sodium: Treatment E
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Drug: Rabeprazole sodium: Treatment C
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Drug: Rabeprazole sodium: Treatment D
The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Drug: Rabeprazole sodium: Treatment A
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
Drug: Rabeprazole sodium: Treatment B
The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
Experimental: Treatment sequence CBDAE
Drug: Rabeprazole sodium: Treatment E
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Drug: Rabeprazole sodium: Treatment C
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Drug: Rabeprazole sodium: Treatment D
The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Drug: Rabeprazole sodium: Treatment A
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
Drug: Rabeprazole sodium: Treatment B
The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
Experimental: Treatment sequence DCEBA
Drug: Rabeprazole sodium: Treatment E
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Drug: Rabeprazole sodium: Treatment C
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Drug: Rabeprazole sodium: Treatment D
The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Drug: Rabeprazole sodium: Treatment A
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
Drug: Rabeprazole sodium: Treatment B
The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
Experimental: Treatment sequence EDACB
Drug: Rabeprazole sodium: Treatment E
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Drug: Rabeprazole sodium: Treatment C
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Drug: Rabeprazole sodium: Treatment D
The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
Drug: Rabeprazole sodium: Treatment A
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
Drug: Rabeprazole sodium: Treatment B
The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rabeprazole plasma concentrations
Time Frame: Day 1
Day 1
Thioether metabolite plasma concentrations
Time Frame: Day 1
Day 1

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The number of patients with adverse events as a measure of safety and tolerability
Time Frame: Approximately 55 days
Approximately 55 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR014821
  • RABGRD1004 (Other Identifier: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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