HealthyPhase 1NCT00648349

Fasting Study of Rabeprazole Sodium Delayed-Release Tablets 20 mg to Aciphex® Delayed-Release Tablets 20 mg

A Phase 1 study testing Rabeprazole Sodium Delayed-Release Tablets 20 mg and Aciphex® Delayed-Release Tablets 20 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.

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

The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium delayed-release 20 mg tablets to Eisai's Aciphex® delayed-release 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fasting conditions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Rabeprazole Sodium Delayed-Release Tablets 20 mg and Aciphex® Delayed-Release Tablets 20 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteUnited States
Study dates: May 2003to Jun 2003
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age: 18 years and older.
Sex: Male and non-pregnant, non-lactating female
Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study.
Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. No hormonal contraceptives or hormonal replacement therapy are permitted in this study. Acceptable forms of contraception include the following:
intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
barrier methods containing or used in conjunction with a spermicidal agent, or

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surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year.
During the course of the study, from study screen until study exit including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form.
Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Who cannot join

Institutionalized subjects will not be used.
Social Habits:
Use of any tobacco products.
Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
Ingestion of any vitamins or herbal products within the 48 hours prior to the initial dose of the study medication.
Any recent, significant change in dietary or exercise habits.

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Medications:
Use of any medication within the 14 days prior to the initial dose of study medication.
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication.
Diseases:
History of any significant chronic disease and/or hepatitis.
History of drug and/or alcohol abuse.
Acute illness at the time of either the pre-study medical evaluation or dosing.
Positive HIV, Hepatitis B, or Hepatitis C test.
Abnormal and clinically significant laboratory test results:
Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
Abnormal and clinically relevant ECG tracing.
Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication.
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
Allergy or hypersensitivity to rabeprazole, any of the inactive ingredients, or other related products.
History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption.
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Trial locations and contacts

1 site in 1 country.

United States1 site

PRACS Institute, Ltd.
Fargo, North Dakota, 58104

Other trials in United States

About this study

Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Rabeprazole Sodium Delayed-Release Tablets (20 mg; Mylan) to Aciphex® Delayed-Release Tablets (20 mg; Eisia) in Healthy Volunteers

Conditions: Healthy
Being tested: Rabeprazole Sodium Delayed-Release Tablets 20 mg, Aciphex® Delayed-Release Tablets 20 mg

What participants receive

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

Rabeprazole Sodium Delayed-Release Tablets 20 mgDrug
20mg, single dose fasting
Aciphex® Delayed-Release Tablets 20 mgDrug
20mg, single dose fasting

Study groups in NCT00648349
Study group	Role	What they receive
1	Experimental	Rabeprazole Sodium Delayed-Release Tablets 20 mg Receives: Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mg
2	Active comparator	Aciphex® Delayed-Release Tablets 20 mg Receives: Drug: Aciphex® Delayed-Release Tablets 20 mg

What is being measured

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

Bioequivalence
Measured: within 30 days

Timeline

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

May 2003Jun 2003

First posted1 Apr 2008 (estimated)
Study startMay 2003
Primary completionJun 2003
Study completionJun 2003

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00648349
Sponsor's protocol ID: RABE-0325
Status last verified: Apr 2024
First submitted: 30 Mar 2008
Last updated: 24 Apr 2024
Results posted: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Rabeprazole Sodium Delayed-Release Tablets (20 mg; Mylan) to Aciphex® Delayed-Release Tablets (20 mg; Eisia) in Healthy Volunteers
ClinicalTrials.gov ID: NCT00648349
Acronym / sponsor ID: RABE-0325
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Jun 2003 (actual)
Study completion: Jun 2003 (actual)
First posted: 1 Apr 2008 (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.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Rabeprazole Sodium Delayed-Release Tablets 20 mgRabeprazole Sodium Delayed-Release Tablets 20 mg
2	Active comparator	Drug: Aciphex® Delayed-Release Tablets 20 mgAciphex® Delayed-Release Tablets 20 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age: 18 years and older.
Sex: Male and non-pregnant, non-lactating female
Weight: At least 60 kg (132 lbs) for men and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of ""Desirable Weights of Adults"" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS).
All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication.

Key exclusion criteria (23 listed)

Institutionalized subjects will not be used.
Social Habits:
Medications:
Diseases:
Abnormal and clinically significant laboratory test results:

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 Delayed-Release Tablets 20 mg20mg, single dose fasting	Drug	1
Aciphex® Delayed-Release Tablets 20 mg20mg, single dose fasting	Drug	2

Primary outcome

Bioequivalence
Time frame: within 30 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 24 Apr 2024.
Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.

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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.

James D Carlson, Pharm. D. principal investigator

PRACS Institute Ltd.

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

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 10 inclusion and 23 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 24 Apr 2024. 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 United States. 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 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?

Bioequivalence (time frame: within 30 days). 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 NCT00648349.

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 24 Apr 2024.