HealthyPhase 1NCT01179659
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
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 Canada.
Trial summary
The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions. 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?
- 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
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2005to Mar 2006
- 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, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
- Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
- Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:
- Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
- Intrauterine device (IUD) in place for at least 3 months.
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- Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
- Surgical sterilization of the partner (vasectomy for 6 months minimum).
- Hormonal contraceptives for at least 3 months prior to the first dose of the study.
- Gave voluntary written informed consent to participate in the study.
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- Alcoholism or drug abuse within the past 2 years;
- Hypersensitivity or idiosyncratic reaction to pantoprazole, omeprazole, or any other substituted benzimidazole proton-pump. inhibitors.
- Females who were pregnant or lactating.
- History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
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- Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
- Treatment with any known enzyme-altering drugs (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to the first dose.
- Difficulty in swallowing medication or any gastrointestinal disease that would affect the drug absorption.
- Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
- Subjects who, through completion of the study, would have donated in excess of:
- 500 mL of blood in 14 days;
- 1500 mL of blood in 180 days;
- 2500 mL of blood in one years.
- Subjects who participated in another clinical trial with 28 days prior to the first dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pharmacokinetic Study to Assess the Bioequivalence of a Single-Dose of KUDCO and Wyeth Pharmaceuticals (Protonix) 40 mg Pantoprazole Sodium Delayed-Release Tablet When Administered to Healthy Adult Volunteers Under Fed Conditions
The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.
Read the detailed description
This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed conditions.
- Conditions
- Healthy
- Being tested
- Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
- Keywords
- Single dose crossover BE study
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
Single dose crossover BE study
| Study group | Role | What they receive |
|---|---|---|
| Protonix | Active comparator | Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals) Receives: Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet |
| Pantoprazole 40 mg DR Tablet | Experimental | Pantoprazole 40 mg DR Tablet vs. Protonix 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: 26 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Measured: 26 hours
AUC0-inf (area under the concentration-time curve from time zero to infinity)
Measured: 26 hours
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 startSep 2005
- Primary completionNov 2005
- Study completionMar 2006
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kremers Urban Development Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gaetano morelli, MD, Principal investigator, MDS Pharma Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179659
- Sponsor's protocol ID
- SP872
- 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 Assess the Bioequivalence of a Single-Dose of KUDCO and Wyeth Pharmaceuticals (Protonix) 40 mg Pantoprazole Sodium Delayed-Release Tablet When Administered to Healthy Adult Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT01179659
- Acronym / sponsor ID
- SP872
- Conditions
- Healthy
- Keywords
- Single dose crossover BE study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Kremers Urban Development CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Nov 2005 (actual)
- Study completion
- Mar 2006 (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 assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.
Detailed description
This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed conditions.
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 (Wyeth Pharmaceuticals) |
| Pantoprazole 40 mg DR Tablet | Experimental | Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR TabletPantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
- Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
- Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
- Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:
- Gave voluntary written informed consent to participate in the study.
Key exclusion criteria (15 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
- In addition, history or presence of:
- Females who were pregnant or lactating.
- History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
- Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
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 TabletSingle dose crossover BE study | Drug | Pantoprazole 40 mg DR Tablet, Protonix |
Primary outcome
Cmax (maximum observed concentration of drug substance in plasma)
Time frame: 26 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
Time frame: 26 hours
AUC0-inf (area under the concentration-time curve from time zero to infinity)
Time frame: 26 hours
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.
Gaetano morelli, MD 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 Canada.
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 15 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 Canada. 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: 26 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.