HealthyPhase 1NCT01418417
Bioequivalence Study of Torrent Pharmaceutical Limited's Pantoprazole Sodium 40 mg Delayed Release Tablets Under Fasting Conditions
A Phase 1 study testing Torrent's Pantoprazole Sodium Delayed - Release Tablets in people with Healthy, run by Torrent Pharmaceuticals Limited at 1 site in India.
Trial summary
Objective: To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7 days. 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?
- Torrent's Pantoprazole Sodium Delayed - Release Tablets
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 1 siteIndia
- Study dates
- Start not givento not given
- 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 human adult subjects between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
- Subjects who have no evidence of underlying disease during screening history and whose physical examination is performed within 21 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 11.3 of the protocol.
- Female Subjects:
- Of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
- Postmenopausal for at least 1 year.
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
Who cannot join
- History or presence of significant:
- Cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
- Alcohol dependence, alcohol abuse or drug abuse within past one year.
- Moderate to heavy smoking (>10 cigarettes/day) or consumption of tobacco products.
- History of difficulty in swallowing tablet / capsule.
- Clinically significant illness within 4 weeks before the start of the study
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- Asthma, urticaria or other allergic type reactions after taking any medication.
- Positive urine drug screening, HIV, Hepatitis B \& C tests.
- Any history of hypersensitivity to Pantoprazole Sodium.
- Existence of any surgical or medical condition, which, in the judgment of clinical investigator might interfere with the pharmacokinetics of the drug or likely to compromise the safety of the subject.
- Inability to communicate or co-operate with the investigator due to language problem, attitude, poor mental development / impaired cerebral function.
- Subject who has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks prior to the start of the study.
- Subjects who have:
- Systolic blood pressure less than 90 mm of Hg or more than 150 mm of Hg.
- Diastolic blood pressure less than 60 mm of Hg or more than 94 mm of Hg. 3) Minor deviations (2-4 mm Hg) at check-in may be acceptable at the discretion of the physician /investigator.
- 4) Pulse rate below 50/minute or above 105/minute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets of Torrent Pharmaceutical Limited., India and Protonix® (Pantoprazole Sodium) 40 mg Delayed Release Tablets of Wyeth Pharmaceuticals Inc, in Healthy Human Adult Subjects, Under Fasting Conditions
Objective:
To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7 days.
Study Design:
randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects
- Conditions
- Healthy
- Being tested
- Torrent's Pantoprazole Sodium Delayed - Release Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torrent's Pantoprazole Sodium Delayed - Release TabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax parameter
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for Cmax
Bioequivalence based AUC parameter
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUC(o-t).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
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
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01418417
- Sponsor's protocol ID
- 1200/07
- Status last verified
- Aug 2011
- First submitted
- 10 Aug 2011
- Last updated
- 17 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Two Treatment, Two Period, Two Sequence, Single Dose, Crossover, Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets of Torrent Pharmaceutical Limited., India and Protonix® (Pantoprazole Sodium) 40 mg Delayed Release Tablets of Wyeth Pharmaceuticals Inc, in Healthy Human Adult Subjects, Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01418417
- Acronym / sponsor ID
- 1200/07
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- First posted
- 17 Aug 2011 (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.
Objective:
To compare the single dose bioavailability of Torrent's Pantoprazole Sodium Delayed - Release Tablets 1 × 40 mg and PROTONIX® (Pantoprazole Sodium) Delayed - Release Tablets 1 × 40 mg of Wyeth Pharmaceutical Inc. Dosing periods were separated by a washout period of at least 7 days.
Study Design:
randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects
Study design
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy human adult subjects between 18-55 years of age (inclusive), having a body mass index (BMI) between 18 and 27 kg/m2.
- Subjects who have no evidence of underlying disease during screening history and whose physical examination is performed within 21 days prior to commencement of the study.
- Subjects whose screening laboratory values are within normal limits or considered by the physician/Principal Investigator to be of no clinical significance.
- Informed consent given in written form according to section 11.3 of the protocol.
- Female Subjects:
Key exclusion criteria (16 listed)
- History or presence of significant:
- Subject who has participated in any other clinical trial involving drug administration and collection of blood samples or has donated blood in the preceding 12 weeks prior to the start of the study.
- Subjects who have:
- 4) Pulse rate below 50/minute or above 105/minute.
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 |
|---|---|---|
| Torrent's Pantoprazole Sodium Delayed - Release Tablets | Drug | – |
Primary outcome
Bioequivalence based on Cmax parameter
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for Cmax
Bioequivalence based AUC parameter
bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUC(o-t).
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 17 Aug 2011.
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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 Phase 1 study testing Torrent's Pantoprazole Sodium Delayed - Release Tablets in people with Healthy, run by Torrent Pharmaceuticals 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 8 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 17 Aug 2011. 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.
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 based on Cmax parameter. 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?
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 17 Aug 2011.