HealthyPhase 1NCT01179646
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets
A Phase 1 study testing Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet in people with Healthy, run by Kremers Urban Development Company at 1 site in United States.
Trial summary
The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single… Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Aug 2004
- 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non tobacco/nicotine-using (6 months minimum) healthy males and females between 19 and 50 years of age.
- Body weight from 15% below or 15% above, inclusive, the ideal weight for height and estimated frame, as adapted from the 1983 Metropolitan Life Table.
- Female subjects were surgically sterile, at least two years postmenopausal, or if sexually active, had a partner who had been vasectomized for at least 6 months, or agreed to utilize one of the following forms of contraception: barrier (condom with spermicide or diaphragm with spermicide), IUD, or hormonal (oral, implant, transdermal patch, or injection) for the following specified times.
- Subjects using hormonal contraceptives were on a stable dose for 3 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. Subjects having an intrauterine device (IUD) must have had the IUD in place for at least 2 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. For other forms of birth control, the subject had used the method at least 2 weeks prior to screening and agreed to use the method through completion of the study.
- Voluntary consent to participate in this study as demonstrated by signing the informed consent form.
Who cannot join
- Persons of Asian origin.
- Females who were pregnant or lactating.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or impact the validity of the study results.
- History of hypersensitivity, allergic or adverse response to pantoprazole or related drugs.
- Positive results from HIV antibody screen, hepatitis B surface antigen screen, and/or hepatitis C antibody screen.
- Participation in a previous clinical trial within 30 days prior to study initiation.
Show all 18Show fewer
- Donation of one pint or more of whole blood within 56 days prior to study initiation.
- Donation of 2 units of red blood cells within 112 days prior to study initiation.
- Donation of plasma with 7 days prior to study initiation.
- Difficulty in swallowing medication or any gastrointestinal disease that could affect the drug absorption.
- Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation. Examples included, but were not limited to, vegetarian, fasting, or liquid supplement, etc.
- Treatment with any known enzyme-altering agents (barbiturates, phenothiazines, or cimetidine, etc.) within 30 days prior to study initiation.
- Use of any prescription medication (except hormonal contraceptives for females) within 14 days prior to study initiation.
- Use of any over-the-counter (OTC) medication, including mega-dose vitamins, analgesics, herbal/nutritional supplements, and antacids, within 7 days prior to study initiation.
- Positive urine screen for alcohol or drugs of abuse.
- Unwilling to eat the food as provided in the study menu.
- Hemoglobin <12.0 g/dL.
- History of alcohol or drug abuse within 2 years prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State
The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.
Read the detailed description
The 90% CI for pantoprazole ln(Cmax), ln[AUC(0-t)], and ln[AUC(0-inf)] for the comparison of the test product (pantoprazole) versus the reference product (Protonix) should be within the 80 to 125% range required for the conclusion of bioequivalence.
- Conditions
- Healthy
- Being tested
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Keywords
- Bioequivalency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletDrug
Also called Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
Single dose crossover BE study
| Study group | Role | What they receive |
|---|---|---|
| Protonix | Active comparator | Protonix 40 mg DR Tablet Receives: Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet |
| Pantoprazole | Experimental | Pantoprazole 40 mg DR Tablet Receives: Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (maximum observed concentration of drug substance in plasma)
Measured: 16 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Measured: 16 hours
AUC0-inf area under the concentration-time curve from time zero to infinity)
Measured: 16 hoyurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJun 2004
- Primary completionJun 2004
- Study completionAug 2004
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kremers Urban Development Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan Marion, MD, PhD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179646
- Sponsor's protocol ID
- SP796
- Status last verified
- Aug 2010
- First submitted
- 10 Aug 2010
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State
- ClinicalTrials.gov ID
- NCT01179646
- Acronym / sponsor ID
- SP796
- Conditions
- Healthy
- Keywords
- Bioequivalency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Kremers Urban Development CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Jun 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 11 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 objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.
Detailed description
The 90% CI for pantoprazole ln(Cmax), ln[AUC(0-t)], and ln[AUC(0-inf)] for the comparison of the test product (pantoprazole) versus the reference product (Protonix) should be within the 80 to 125% range required for the conclusion of bioequivalence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Protonix | Active comparator | Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletProtonix 40 mg DR Tablet |
| Pantoprazole | Experimental | Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletPantoprazole 40 mg DR Tablet |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Non tobacco/nicotine-using (6 months minimum) healthy males and females between 19 and 50 years of age.
- Body weight from 15% below or 15% above, inclusive, the ideal weight for height and estimated frame, as adapted from the 1983 Metropolitan Life Table.
- Female subjects were surgically sterile, at least two years postmenopausal, or if sexually active, had a partner who had been vasectomized for at least 6 months, or agreed to utilize one of the following forms of contraception: barrier (condom with spermicide or diaphragm with spermicide), IUD, or hormonal (oral, implant, transdermal patch, or injection) for the following specified times.
- Subjects using hormonal contraceptives were on a stable dose for 3 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. Subjects having an intrauterine device (IUD) must have had the IUD in place for at least 2 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. For other forms of birth control, the subject had used the method at least 2 weeks prior to screening and agreed to use the method through completion of the study.
- Voluntary consent to participate in this study as demonstrated by signing the informed consent form.
Key exclusion criteria (18 listed)
- Persons of Asian origin.
- Females who were pregnant or lactating.
- History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or impact the validity of the study results.
- History of hypersensitivity, allergic or adverse response to pantoprazole or related drugs.
- Positive results from HIV antibody screen, hepatitis B surface antigen screen, and/or hepatitis C antibody screen.
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 |
|---|---|---|
| Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletAlso: Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)Single dose crossover BE study | Drug | Pantoprazole, Protonix |
Primary outcome
Cmax (maximum observed concentration of drug substance in plasma)
Time frame: 16 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Time frame: 16 hours
AUC0-inf area under the concentration-time curve from time zero to infinity)
Time frame: 16 hoyurs
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 11 Aug 2010.
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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.
Alan Marion, MD, PhD principal investigator
MDS Pharma Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet in people with Healthy, run by Kremers Urban Development Company at 1 site in United States.
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 18 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 11 Aug 2010. 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?
Cmax (maximum observed concentration of drug substance in plasma) (time frame: 16 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2010.