HealthyPhase 1NCT01241409

A Bioequivalence Study of 2 Formulations of Rabeprazole Sodium and Evaluation of the Effect of Food on Rabeprazole Sodium in Healthy Adult Volunteers

A Phase 1 study testing Rabeprazole sodium: Treatment A, Rabeprazole sodium: Treatment B and Rabeprazole sodium: Treatment C in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..

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

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 A, Rabeprazole sodium: Treatment B and Rabeprazole sodium: Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 78 participants
Where: No sites listed yet
Study dates: Oct 2010to Dec 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

Have a body mass index (BMI) between 18 and 30 kg/m² (inclusive), and body weight not less than 50 kg
Women 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
Women must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
Men must agree to use an adequate contraception method as deemed appropriate by the investigator
Have normal blood pressure between 90 and 140 mmHg systolic and <=90 mmHg diastolic

Who cannot join

Currently have, or have a history of medical illness considered by the Investigator to be clinically significant or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
Have clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator
Have clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
Have a history of drug or alcohol abuse within the past 1 year
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

Show all 10Show fewer

Known allergy to the study drug or any of the excipients of the formulation
Known allergy to heparin or history of heparin-induced thrombocytopenia
Use of any concomitant therapy which are drug metabolizing enzyme (cytochrome P450) inducers or inhibitors within 6 weeks before study entry and during the entire study
Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, hormonal contraceptives and hormonal replacement therapy, within 14 days before the first dose of the study drug is scheduled

About this study

Official title: Pivotal Study to Assess the Bioequivalence of the To-be-Marketed Sprinkle Capsule Formulation and the Phase 3 Sprinkle Capsule Formulation of Rabeprazole Sodium in Fasted Condition and to Assess the Effect of Food on the To-be-Marketed Formulation in Healthy Adult Subjects

The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 sprinkle capsule formulations of rabeprazole sodium when administered without food to healthy volunteers. In addition, the pharmacokinetics of 1 formulation of rabeprazole sodium will be evaluated when administered with food to healthy volunteers.

Read the detailed description

This is a randomized (study drug assigned by chance), open-label (the volunteer will know the treatment/drug they are taking), single-dose study of 2 formulations of rabeprazole sodium in healthy adult volunteers. Rabeprazole sodium is a drug used to treat patients with Gastroesophageal Reflux Disease (GERD), a condition where the esophagus (tube from throat to stomach) becomes irritated or inflamed as a result of acid that backs up into the esophagus from the stomach. All volunteers will receive 3 doses of study drug; each dose of study drug will be separated by at least 7 days. Blood samples will be collected from volunteers during the study to measure the concentration of study drug. Approximately 78 healthy volunteers will be enrolled and will participate in the study for a total of approximately 39 days. During the study, the healthy volunteer will make a total of approximately 4 visits to the study center. The 4 visits will include an initial screening visit and 3 visits to receive study drug. Volunteers will be required to stay at the study center for at least 12 hours before study drug administration and up to approximately 24 hours after study drug administration to have study procedures performed and blood samples collected to measure the concentrations of rabeprazole and its thioether metabolite (a substance produced when rabeprazole is metabolized in the body) in the plasma (ie, the clear liquid portion of blood). Volunteers will be monitored for safety throughout the study. Healthy volunteers will receive a single dose of study drug in 3 treatment periods. In each treatment period, healthy volunteers will receive one 10 mg capsule of rabeprazole sodium or two 5 mg capsules of rabeprazole sodium. The contents of study drug capsules will be sprinkled on 1 tablespoon of applesauce and administered orally (by mouth) to healthy volunteers in the morning who have fasted (not eaten) overnight and to those who have eaten a standardized breakfast.

Conditions: Healthy
Being tested: Rabeprazole sodium: Treatment A, Rabeprazole sodium: Treatment B, Rabeprazole sodium: Treatment C
Keywords: Healthy, Sprinkle Capsule Formulation, Rabeprazole sodium, Pharmacokinetics, Bioequivalence, Safety

What participants receive

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

Rabeprazole sodium: Treatment ADrug
One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
Rabeprazole sodium: Treatment BDrug
One single oral dose of 10 mg (2 x 5-mg capsules) rabeprazole Phase 3 sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
Rabeprazole sodium: Treatment CDrug
One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered after consumption of a standardized high-fat high-caloric breakfast. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).

Study groups in NCT01241409
Study group	Role	What they receive
Treatment sequence ABC	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C
Treatment sequence ACB	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C
Treatment sequence BAC	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C
Treatment sequence BCA	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C
Treatment sequence CAB	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C
Treatment sequence CBA	Experimental	Not described Receives: Drug: Rabeprazole sodium: Treatment A; Drug: Rabeprazole sodium: Treatment B; Drug: Rabeprazole sodium: Treatment C

What is being measured

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

Plasma concentrations of rabeprazole sodium
Measured: Up to 16 hours after each study drug administration
Plasma concentrations of thioether metabolite
Measured: Up to 16 hours after each study drug administration

Secondary outcomes (1)

The number of participants with adverse events as a measure of safety and tolerability
Measured: Up to approximately 39 days

Timeline

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

Oct 2010Dec 2010

First posted16 Nov 2010 (estimated)
Study startOct 2010
Primary completionDec 2010
Study completionDec 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: 78 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01241409
Sponsor's protocol ID: CR014830
Other IDs: RABGRD1007
Status last verified: Oct 2012
First submitted: 21 Oct 2010
Last updated: 30 Oct 2012
Results posted: No

Publications

Thyssen A, Solanki B, Gonzalez M, Leitz G, Treem W, Mannaert E. Pharmacokinetics of rabeprazole granules versus tablets, and the effect of food on the pharmacokinetics of rabeprazole granules in healthy adults-cross-study comparison. Clin Pharmacol Drug Dev. 2014 Sep;3(5):406-16. doi: 10.1002/cpdd.118. Epub 2014 May 23.
PubMed 27129014

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?

Official record

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pivotal Study to Assess the Bioequivalence of the To-be-Marketed Sprinkle Capsule Formulation and the Phase 3 Sprinkle Capsule Formulation of Rabeprazole Sodium in Fasted Condition and to Assess the Effect of Food on the To-be-Marketed Formulation in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT01241409
Acronym / sponsor ID: CR014830
Conditions: Healthy
Keywords: Healthy, Sprinkle Capsule Formulation, Rabeprazole sodium, Pharmacokinetics, Bioequivalence, Safety
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 78 participants (actual)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 16 Nov 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.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment sequence ABC	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C
Treatment sequence ACB	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C
Treatment sequence BAC	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C
Treatment sequence BCA	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C
Treatment sequence CAB	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C
Treatment sequence CBA	Experimental	Drug: Rabeprazole sodium: Treatment A, Drug: Rabeprazole sodium: Treatment B, Drug: Rabeprazole sodium: Treatment C

Who may qualify

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

Key inclusion criteria (5 listed)

Have a body mass index (BMI) between 18 and 30 kg/m² (inclusive), and body weight not less than 50 kg
Women 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
Women must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at screening and a negative urine pregnancy test on Day -1 of each treatment period
Men must agree to use an adequate contraception method as deemed appropriate by the investigator
Have normal blood pressure between 90 and 140 mmHg systolic and <=90 mmHg diastolic

Key exclusion criteria (10 listed)

Currently have, or have a history of medical illness considered by the Investigator to be clinically significant or any other illness that the investigator considers should exclude the volunteer or that could interfere with the interpretation of the study results
Have clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening as deemed appropriate by the investigator
Have clinically significant abnormal physical examination, vital signs or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the investigator
Have a history of drug or alcohol abuse within the past 1 year
Have a history of smoking or use of nicotine-containing substances within the previous 2 months

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 AOne single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
Rabeprazole sodium: Treatment BOne single oral dose of 10 mg (2 x 5-mg capsules) rabeprazole Phase 3 sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA
Rabeprazole sodium: Treatment COne single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered after consumption of a standardized high-fat high-caloric breakfast. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).	Drug	Treatment sequence ABC, Treatment sequence ACB, Treatment sequence BAC, Treatment sequence BCA, Treatment sequence CAB, Treatment sequence CBA

Primary outcome

Plasma concentrations of rabeprazole sodium
Time frame: Up to 16 hours after each study drug administration
Plasma concentrations of thioether metabolite
Time frame: Up to 16 hours after each study drug administration

1 secondary outcome

The number of participants with adverse events as a measure of safety and tolerability
Time frame: Up to approximately 39 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 30 Oct 2012.
Derived from this study: PubMed 27129014Thyssen A, Solanki B, Gonzalez M, Leitz G, Treem W, Mannaert E. Pharmacokinetics of rabeprazole granules versus tablets, and the effect of food on the pharmacokinetics of rabeprazole granules in healthy adults-cross-study comparison. Clin Pharmacol Drug Dev. 2014 Sep;3(5):406-16. doi: 10.1002/cpdd.118. Epub 2014 May 23.

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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?

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 10 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 30 Oct 2012. 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?

Plasma concentrations of rabeprazole sodium (time frame: Up to 16 hours after each study drug administration). 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 NCT01241409, 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 30 Oct 2012.