HealthyNCT01654718
Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fed Study
A study testing Pantoprazole in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
Trial summary
This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. Read more about this study
- Who is it for?
- Ages 20 to 37 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pantoprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2008to Nov 2009
- Phase
- Interventional
- 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 20 to 37 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers who met the following criteria were included in the study
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
- Had non-vegetarian dietary habit.
- There were no deviations in this regard
Who cannot join
- History of allergy or hypersensitivity to Pantoprazole and/or any other drugs.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were out of acceptable limits for haemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
- Presence of values which were out of acceptable limits for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
Show all 16Show fewer
- Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/HPF), epithelial cells (>4/HPF), glucose (positive) or protein (positive).
- Clinically abnormal ECG or Chest X-ray.
- History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
- History of any psychiatric illness which might impair the ability to provide written informed consent.
- Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
- History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
- Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
- Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
- Subjects who, through completion of this study, would have donated and /or lost more than 350 ml of blood in the past 3 months other than study participation.
- There were no deviations in this regard.
Trial locations and contacts
1 site in 1 country.
India1 site
Clinical Pharmacology Unit, Ranbaxy Laboratories Limited
Noida, Uttar Pradesh
About this study
Official title: An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioequivalence Study Comparing Pantoprazole Sodium 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate is Equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a Subsidiary of Ranbaxy Pharmaceuticals Inc. USA) With PROTONIX® 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate is Equivalent to 40 mg of Pantoprazole) of Wyeth Laboratories in Healthy, Adult, Human, Male Subjects Under Fed Conditions.
This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth Laboratories, USA in healthy, adult, human, male subjects under fed conditions.
Read the detailed description
The study was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence under fed conditions
A washout period of 08 days was enforced between the administrations of study drugs in each period. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at periodic interval up to 48.00 hour in each period. A total number of blood draws during the study were sixty six (66) and the total volume of blood drawn did not exceed 324 mL.
Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of Pantoprazole delayed release tablet 40 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period.
- Conditions
- Healthy
- Being tested
- Pantoprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PantoprazoleDrug
Pantoprazole 40mg Delayed release tablets (Test Product)
PantoprazoleDrug
Protonix® Delayed Release 40 mg tablets (Reference product)
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole Sodium Delayed release tablets | Experimental | Pantoprazole Sodium Delayed release tablets USP 40 mg of OHM Laboratories Inc.,USA Receives: Drug: Pantoprazole |
| Protonix® Delayed Release 40 mg tablets | Active comparator | Protonix® Delayed Release 40 mg tablets of Wyeth Pharmaceuticals Inc.USA Receives: Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Pharmacokinetics
Cmax, Area Under Curve and Tmax
Measured: Predose and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 22.00, 24.00, 36.00 and 48.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startOct 2008
- Primary completionNov 2008
- Study completionNov 2009
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654718
- Sponsor's protocol ID
- 251_PANTO_08
- Status last verified
- Jun 2012
- First submitted
- 21 Jun 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioequivalence Study Comparing Pantoprazole Sodium 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate is Equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a Subsidiary of Ranbaxy Pharmaceuticals Inc. USA) With PROTONIX® 40 mg Delayed Release Tablets (Containing 45.1 mg of Pantoprazole Sodium Sesquihydrate is Equivalent to 40 mg of Pantoprazole) of Wyeth Laboratories in Healthy, Adult, Human, Male Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT01654718
- Acronym / sponsor ID
- 251_PANTO_08
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 1 Aug 2012 (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.
This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth Laboratories, USA in healthy, adult, human, male subjects under fed conditions.
Detailed description
The study was an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence under fed conditions
A washout period of 08 days was enforced between the administrations of study drugs in each period. At study check-in, the subjects reported to the clinical site at least 36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing. Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after dose administration at periodic interval up to 48.00 hour in each period. A total number of blood draws during the study were sixty six (66) and the total volume of blood drawn did not exceed 324 mL.
Following an overnight fast of at least 10 hour, a high-fat high-calorie breakfast was served to the study subjects. Thirty minutes after start of this breakfast, a single oral dose of Pantoprazole delayed release tablet 40 mg of either test or reference formulation was administered during each period of the study, along with 240 mL of drinking water at ambient temperature under low light condition and under supervision of trained study personnel. Both test and reference products were administered to all the study subjects, one in each period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole Sodium Delayed release tablets | Experimental | Drug: PantoprazolePantoprazole Sodium Delayed release tablets USP 40 mg of OHM Laboratories Inc.,USA |
| Protonix® Delayed Release 40 mg tablets | Active comparator | Drug: PantoprazoleProtonix® Delayed Release 40 mg tablets of Wyeth Pharmaceuticals Inc.USA |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Volunteers who met the following criteria were included in the study
- Were in the age range of 18-45 years.
- Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
- Had voluntarily given written informed consent to participate in this study.
- Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
Key exclusion criteria (16 listed)
- History of allergy or hypersensitivity to Pantoprazole and/or any other drugs.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
- Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
- Presence of values which were out of acceptable limits for haemoglobin, total white blood cells count, differential WBC count or platelet count.
- Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
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 |
|---|---|---|
| PantoprazolePantoprazole 40mg Delayed release tablets (Test Product) | Drug | Pantoprazole Sodium Delayed release tablets |
| PantoprazoleProtonix® Delayed Release 40 mg tablets (Reference product) | Drug | Protonix® Delayed Release 40 mg tablets |
Primary outcome
Composite of Pharmacokinetics
Time frame: Predose and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 22.00, 24.00, 36.00 and 48.00 hours
Cmax, Area Under Curve and Tmax
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 1 Aug 2012.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pantoprazole in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in India.
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 7 inclusion and 16 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 1 Aug 2012. 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 India. 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.
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?
Composite of Pharmacokinetics (time frame: Predose and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 22.00, 24.00, 36.00 and 48.00 hours). 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 1 Aug 2012.