HealthyPhase 1NCT02680119
BE of Torrent's Esomeprazole Mg DR Capsules
A Phase 1 study testing Nexium 40 mg DR Capsules of AstraZeneca LP, USA. and Torrent's Esomeprazole Magnesium DR Capsules 40 mg in people with Healthy, run by Torrent Pharmaceuticals Limited.
Trial summary
Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days. 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
- Healthy
- What is being tested?
- Nexium 40 mg DR Capsules of AstraZeneca LP, USA. and Torrent's Esomeprazole Magnesium DR Capsules 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- May 2011to May 2011
- 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
- Sex: male
- Age: 18-45 years
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
- Non-smokers or smoker who smokes less than 10 cigarettes per day.
Who cannot join
- Inability to communicate or co-operate.
- Administration of any study drug in the period 0 to 3 months before entry to the study,
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of pre-existing bleeding disorder.
- Clinically relevant abnormalities in the results of the laboratory screening evaluation.
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- Clinically significant abnormal ECG or Chest X-ray.
- HIV, HCV, HBsAg positive volunteers.
- History of alcohol or drug abuse.
- History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study.
- Positive to Breath alcohol test.
- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
- Systolic blood pressure less than 100 mmHg or more than 140 mmHg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
- Pulse rate less than 50/minute or more than 100/minute.
- Oral temperature less than 95°F or more than 98.6°F.
- Respiratory rate less than 12/minute or more than 20/minute.
- History of allergy to the test drug or any drug chemically similar to the drug under investigation.
- Recent History of kidney or liver dysfunction.
- Volunteers suffering from any psychiatric (acute or chronic) disorder.
- Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
About this study
Official title: An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE Study of Esomeprazole Mg DR Capsule 40 mg [Torrent] Versus Nexium [AastraZeneca]- Sprinkled Over Apple Sauce in Subjects-Fasting Condition
Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.
Read the detailed description
An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg [ Test Formulation, Torrent Pharmaceutical Ltd., India] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg [Reference Formulation, AastraZeneca LP, USA] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.
- Conditions
- Healthy
- Being tested
- Nexium 40 mg DR Capsules of AstraZeneca LP, USA., Torrent's Esomeprazole Magnesium DR Capsules 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexium 40 mg DR Capsules of AstraZeneca LP, USA.Drug
Also called esomeprazole magnesium delayed release capsules
oral, crossover
Torrent's Esomeprazole Magnesium DR Capsules 40 mgDrug
Also called esomeprazole magnesium delayed release capsules
oral, crossover
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Torrent's Esomeprazole Magnesium DR Capsules 40 mg Receives: Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mg |
| Reference | Active comparator | Nexium 40 mg DR Capsules of AstraZeneca LP, USA Receives: Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Pharmacokinetic Evaluation
Measured: Pre-dose to 20 hour post dose
AUC
Pharmacokinetic Evaluation
Measured: Pre-dose to 20 hour post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startMay 2011
- Primary completionMay 2011
- Study completionMay 2011
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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torrent Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680119
- Sponsor's protocol ID
- PK-10-181
- Status last verified
- Jan 2016
- First submitted
- 2 Feb 2016
- Last updated
- 11 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE Study of Esomeprazole Mg DR Capsule 40 mg [Torrent] Versus Nexium [AastraZeneca]- Sprinkled Over Apple Sauce in Subjects-Fasting Condition
- ClinicalTrials.gov ID
- NCT02680119
- Acronym / sponsor ID
- PK-10-181
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 11 Feb 2016 (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.
Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule 1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA. Dosing periods of studies were separated by a washout period of 5 days.
Detailed description
An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg [ Test Formulation, Torrent Pharmaceutical Ltd., India] Versus Nexium 40 mg DR Capsule containing Esomeprazole 40 mg [Reference Formulation, AastraZeneca LP, USA] Under administered as the contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting Condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Drug: Torrent's Esomeprazole Magnesium DR Capsules 40 mgTorrent's Esomeprazole Magnesium DR Capsules 40 mg |
| Reference | Active comparator | Drug: Nexium 40 mg DR Capsules of AstraZeneca LP, USA.Nexium 40 mg DR Capsules of AstraZeneca LP, USA |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sex: male
- Age: 18-45 years
- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
- Healthy and willing to participate in the study.
- Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
Key exclusion criteria (20 listed)
- Inability to communicate or co-operate.
- Administration of any study drug in the period 0 to 3 months before entry to the study,
- History of significant blood loss due to any reason, including blood donation in the past 3 months.
- Volunteers suffering from any chronic illness such as arthritis, asthma etc.
- History of pre-existing bleeding disorder.
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 |
|---|---|---|
| Nexium 40 mg DR Capsules of AstraZeneca LP, USA.Also: esomeprazole magnesium delayed release capsulesoral, crossover | Drug | Reference |
| Torrent's Esomeprazole Magnesium DR Capsules 40 mgAlso: esomeprazole magnesium delayed release capsulesoral, crossover | Drug | Test |
Primary outcome
Cmax
Time frame: Pre-dose to 20 hour post dose
Pharmacokinetic Evaluation
AUC
Time frame: Pre-dose to 20 hour post dose
Pharmacokinetic Evaluation
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 Feb 2016.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nexium 40 mg DR Capsules of AstraZeneca LP, USA. and Torrent's Esomeprazole Magnesium DR Capsules 40 mg in people with Healthy, run by Torrent Pharmaceuticals Limited.
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 6 inclusion and 20 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 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: Pre-dose to 20 hour post dose). 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 11 Feb 2016.