FastingPhase 1NCT01283919
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
A Phase 1 study testing Pantoprazole Sodium in people with Fasting, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Pantoprazole Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2004to Dec 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects will provide written informed consent.
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study.
- Have normal EcG, X-ray and vital signs.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
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- If subject is a female volunteer and
- Is 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.
- is postmenopausal for at least 1 year.
- is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
Who cannot join
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 or BP≥140/90
- History of hypersensitivity or idiosyncratic reaction to pantoprazole or other proton pump inhibitors.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
- Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within the past 30 days prior to start of clinical period.
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- History of any psychiatric illness, which may impair the ability to provide written, informed consent.
- Subjects who have a history of alcohol or substance abuse within the last 5 years.
- Subjects with clinically significant abnormal values of laboratory parameters.
- Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
- Subjects with positive urine screen for drugs of abuse.
- Any subject in whom pantoprazole is contraindicated for medical reasons.
- Female volunteers demonstrating a positive pregnancy screen.
- Female volunteers who are currently breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Two-treatment, Two-period, Two-sequence,Single Dose, Crossover Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets (Dr. Reddy's Laboratories Ltd, India) to be Compared With Protonix® 40 mg (Pantoprazole Sodium) Delayed Release Tablets (Wyeth Laboratories, USA) in Healthy, Adult, Human Subjects Under Fasting Conditions.
To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.
Read the detailed description
This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.
- Conditions
- Fasting
- Being tested
- Pantoprazole Sodium
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pantoprazole SodiumDrug
Also called Protonix DR Tablets 40 mg
Pantoprazole Sodium DR Tablets 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Pantoprazole Sodium | Experimental | Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited Receives: Drug: Pantoprazole Sodium |
| Protonix | Active comparator | Protonix 40 mg DR Tablets of Wyeth Laboratories Receives: Drug: Pantoprazole Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence on Cmax and AUC parameters
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startOct 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mangesh Kulkarni, M.D, Principal investigator, VimtaLabsLtd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283919
- Sponsor's protocol ID
- PAN/23/87/04-05
- Status last verified
- Jan 2011
- First submitted
- 25 Jan 2011
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Two-treatment, Two-period, Two-sequence,Single Dose, Crossover Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets (Dr. Reddy's Laboratories Ltd, India) to be Compared With Protonix® 40 mg (Pantoprazole Sodium) Delayed Release Tablets (Wyeth Laboratories, USA) in Healthy, Adult, Human Subjects Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT01283919
- Acronym / sponsor ID
- PAN/23/87/04-05
- Conditions
- Fasting
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 26 Jan 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.
To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting conditions.
Detailed description
This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pantoprazole Sodium | Experimental | Drug: Pantoprazole SodiumPantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited |
| Protonix | Active comparator | Drug: Pantoprazole SodiumProtonix 40 mg DR Tablets of Wyeth Laboratories |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects will provide written informed consent.
- Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg.
- Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India height-weight chart for non-medical cases.
- Subjects must be of normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study.
- Have normal EcG, X-ray and vital signs.
Key exclusion criteria (14 listed)
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 or BP≥140/90
- History of hypersensitivity or idiosyncratic reaction to pantoprazole or other proton pump inhibitors.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
- Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
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 SodiumAlso: Protonix DR Tablets 40 mgPantoprazole Sodium DR Tablets 40 mg | Drug | Pantoprazole Sodium, Protonix |
Primary outcome
Bioequivalence on Cmax and AUC parameters
Time frame: 2 months
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 26 Jan 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.
Mangesh Kulkarni, M.D principal investigator
VimtaLabsLtd.
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 Sodium in people with Fasting, run by Dr. Reddy's 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 10 inclusion and 14 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 26 Jan 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 on Cmax and AUC parameters (time frame: 2 months). 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 26 Jan 2011.