HealthyPhase 1NCT01186497
A Relative Bioavailability Study of Rabeprazole Sodium Administered With Different Dosing Vehicles in Healthy Adult Volunteers
A Phase 1 study testing Rabeprazole sodium: Treatment E, Rabeprazole sodium: Treatment C and Rabeprazole sodium: Treatment D in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rabeprazole sodium: Treatment E, Rabeprazole sodium: Treatment C and Rabeprazole sodium: Treatment D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Nov 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Rabeprazole sodium: Treatment E, Rabeprazole sodium: Treatment C, Rabeprazole sodium: Treatment D, Rabeprazole sodium: Treatment A, Rabeprazole sodium: Treatment B
- Keywords
- Healthy, Rabeprazole sodium, Rabeprazole sprinkle capsule granule formulation, Pharmacokinetics, Bioavailability, Safety, Adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodium: Treatment EDrug
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
Rabeprazole sodium: Treatment CDrug
The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
Rabeprazole sodium: Treatment DDrug
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.
Rabeprazole sodium: Treatment ADrug
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.
Rabeprazole sodium: Treatment BDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence AEBDC | Experimental | Not described Receives: Drug: Rabeprazole sodium: Treatment E; Drug: Rabeprazole sodium: Treatment C; Drug: Rabeprazole sodium: Treatment D; Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence BACED | Experimental | Not described Receives: Drug: Rabeprazole sodium: Treatment E; Drug: Rabeprazole sodium: Treatment C; Drug: Rabeprazole sodium: Treatment D; Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence CBDAE | Experimental | Not described Receives: Drug: Rabeprazole sodium: Treatment E; Drug: Rabeprazole sodium: Treatment C; Drug: Rabeprazole sodium: Treatment D; Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence DCEBA | Experimental | Not described Receives: Drug: Rabeprazole sodium: Treatment E; Drug: Rabeprazole sodium: Treatment C; Drug: Rabeprazole sodium: Treatment D; Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence EDACB | Experimental | Not described Receives: Drug: Rabeprazole sodium: Treatment E; Drug: Rabeprazole sodium: Treatment C; Drug: Rabeprazole sodium: Treatment D; Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rabeprazole plasma concentrations
Measured: Day 1
Thioether metabolite plasma concentrations
Measured: Day 1
Secondary outcomes (1)
The number of patients with adverse events as a measure of safety and tolerability
Measured: Approximately 55 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186497
- Sponsor's protocol ID
- CR014821
- Other IDs
- RABGRD1004
- Status last verified
- Jan 2013
- First submitted
- 19 Aug 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
Publications
Thyssen A, Solanki B, Treem W. Randomized, open-label, single-dose, crossover, relative bioavailability study in healthy adults, comparing the pharmacokinetics of rabeprazole granules administered using soft food or infant formula as dosing vehicle versus suspension. Clin Ther. 2012 Jul;34(7):1636-45. doi: 10.1016/j.clinthera.2012.06.008. Epub 2012 Jun 29.
PubMed 22748970
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Rabeprazole Sodium Sprinkle Capsule Formulation Using Different Dosing Vehicles Following Single-dose Administration in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01186497
- Acronym / sponsor ID
- CR014821
- Conditions
- Healthy
- Keywords
- Healthy, Rabeprazole sodium, Rabeprazole sprinkle capsule granule formulation, Pharmacokinetics, Bioavailability, Safety, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 23 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence AEBDC | Experimental | Drug: Rabeprazole sodium: Treatment E, Drug: Rabeprazole sodium: Treatment C, Drug: Rabeprazole sodium: Treatment D, Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence BACED | Experimental | Drug: Rabeprazole sodium: Treatment E, Drug: Rabeprazole sodium: Treatment C, Drug: Rabeprazole sodium: Treatment D, Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence CBDAE | Experimental | Drug: Rabeprazole sodium: Treatment E, Drug: Rabeprazole sodium: Treatment C, Drug: Rabeprazole sodium: Treatment D, Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence DCEBA | Experimental | Drug: Rabeprazole sodium: Treatment E, Drug: Rabeprazole sodium: Treatment C, Drug: Rabeprazole sodium: Treatment D, Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B |
| Treatment sequence EDACB | Experimental | Drug: Rabeprazole sodium: Treatment E, Drug: Rabeprazole sodium: Treatment C, Drug: Rabeprazole sodium: Treatment D, Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Rabeprazole sodium: Treatment EThe contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1. | Drug | Treatment sequence AEBDC, Treatment sequence BACED, Treatment sequence CBDAE, Treatment sequence DCEBA, Treatment sequence EDACB |
| Rabeprazole sodium: Treatment CThe contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1. | Drug | Treatment sequence AEBDC, Treatment sequence BACED, Treatment sequence CBDAE, Treatment sequence DCEBA, Treatment sequence EDACB |
| Rabeprazole sodium: Treatment DThe 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 | Treatment sequence AEBDC, Treatment sequence BACED, Treatment sequence CBDAE, Treatment sequence DCEBA, Treatment sequence EDACB |
| Rabeprazole sodium: Treatment AThe 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 | Treatment sequence AEBDC, Treatment sequence BACED, Treatment sequence CBDAE, Treatment sequence DCEBA, Treatment sequence EDACB |
| Rabeprazole sodium: Treatment BThe 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. | Drug | Treatment sequence AEBDC, Treatment sequence BACED, Treatment sequence CBDAE, Treatment sequence DCEBA, Treatment sequence EDACB |
Primary outcome
Rabeprazole plasma concentrations
Time frame: Day 1
Thioether metabolite plasma concentrations
Time frame: Day 1
1 secondary outcome
The number of patients with adverse events as a measure of safety and tolerability
Time frame: Approximately 55 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 22748970Thyssen A, Solanki B, Treem W. Randomized, open-label, single-dose, crossover, relative bioavailability study in healthy adults, comparing the pharmacokinetics of rabeprazole granules administered using soft food or infant formula as dosing vehicle versus suspension. Clin Ther. 2012 Jul;34(7):1636-45. doi: 10.1016/j.clinthera.2012.06.008. Epub 2012 Jun 29.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rabeprazole sodium: Treatment E, Rabeprazole sodium: Treatment C and Rabeprazole sodium: Treatment D in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 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 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rabeprazole plasma concentrations (time frame: Day 1). 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 NCT01186497, which also lists 1 linked publication.
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 23 Jan 2013.