HealthyPhase 1NCT01170182
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
A Phase 1 study testing Omeprazole and Prilosec® 40 mg in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition. 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?
- Omeprazole and Prilosec® 40 mg
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2006to Apr 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who provided written informed consent.
- Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
- Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
- Subjects with normal ECG, chest X-ray (PA view) and vital signs.
- Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
Who cannot join
None listed.
About this study
Official title: A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.
Read the detailed description
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.
- Conditions
- Healthy
- Being tested
- Omeprazole, Prilosec® 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prelosec 40 mg
Omeprazole Delayed Release Capsules 40 mg
Prilosec® 40 mgDevice
Also called Omeprazole
Prilosec® 40 mg
| Study group | Role | What they receive |
|---|---|---|
| Omeprazole | Experimental | Omeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited Receives: Drug: Omeprazole |
| Prilosec | Active comparator | Prilosec® 40 mg Merck \& Co. Inc Receives: Device: Prilosec® 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence based on Cmax and AUC parameters
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startFeb 2006
- Primary completionApr 2006
- Study completionApr 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Manoj K Bose, Dr., Principal investigator, Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170182
- Sponsor's protocol ID
- 7577/05-06
- Status last verified
- May 2010
- First submitted
- 31 May 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. 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 to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition
- ClinicalTrials.gov ID
- NCT01170182
- Acronym / sponsor ID
- 7577/05-06
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 27 Jul 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.
This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.
Detailed description
This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omeprazole | Experimental | Drug: OmeprazoleOmeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited |
| Prilosec | Active comparator | Device: Prilosec® 40 mgPrilosec® 40 mg Merck \& Co. Inc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects who provided written informed consent.
- Subjects who were healthy within 18-45 years of age, weighing at least 50 kg.
- Body mass index of ≥18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
- Subjects with normal health as determined by medical history and physical examination performed within 15 days prior to the commencement of the study (dosing in period-I).
- Subjects with normal ECG, chest X-ray (PA view) and vital signs.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OmeprazoleAlso: Prelosec 40 mgOmeprazole Delayed Release Capsules 40 mg | Drug | Omeprazole |
| Prilosec® 40 mgAlso: OmeprazolePrilosec® 40 mg | Device | Prilosec |
Primary outcome
Bioequivalence based on Cmax and AUC parameters
Time frame: 4 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 27 Jul 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.
Manoj K Bose, Dr. principal investigator
Vimta Labs Limited, 142, IDA, Phase-II, Cherlapally, Hyderabad, India-500 051
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omeprazole and Prilosec® 40 mg in people with Healthy, run by Dr. Reddy's Laboratories 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 0 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 27 Jul 2010. 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?
Bioequivalence based on Cmax and AUC parameters (time frame: 4 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 27 Jul 2010.