HealthyPhase 1NCT01045642
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions
A Phase 1 study testing Omeprazole in people with Healthy, run by Dr. Reddy's Laboratories Limited at 1 site in India.
Trial summary
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of Procter and Gamble, Cincinnati, Sweden in 38… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2006to Mar 2007
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who provided written informed consent.
- Subjects who were healthy adults within 18-45 years of age (inclusive).
- Body mass index of ≥ 18 kg/m2 and ≤ 25 kglm2 with body weight not less than 50 kg.
- Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of Period-I.
- Had normal ECG, Chest 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.
- 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, or is postmenopausal for at least 1 year, or is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
- Each female subject will be given a urine pregnancy test at check-in for period-I, period-II and post study.
Who cannot join
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 mrn/Hg or BP≥140/90 mrn/Hg
- History of hypersensitivity or idiosyncratic reaction to Omeprazole or any other related drug.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years),diabetes, psychosis or glaucoma will not be eligible for the study
- 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 dosing in Period-1.
Show all 21Show fewer
- 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 who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
- Subjects who are unable to or likely to be non-compliant with protocol requirements or restrictions.
- Any subject in whom Omeprazole is contraindicated for medical reasons
- Subjects who are intolerant to venipuncture
- Subjects with positive urine screen for drugs of abuse. All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each study period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate
- Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing
- Female volunteers demonstrating a positive pregnancy screen.
- All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study
- Female volunteers who are currently breast feeding.
- Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Balanced Randomized,Two-treatment,Two-period,Two-sequence,Single Dose,Crossover Oral Bioequivalence Study of Omeprazole Mg 20mg DR Capsules With Prilosec OTCTM 20mg in 38 Healthy,Adult,Human Subjects Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting conditions.
Read the detailed description
All study related procedures, restrictions, duration, dates and timings, information on the study formulation and confidentiality of subject data were explained clearly to the volunteers by clinical personnel at the time of obtaining informed consent. Volunteers who signed the consent form and showed"their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study.
- Conditions
- Healthy
- Being tested
- Omeprazole
- Keywords
- Bioequivalence, Omeprazole, Crossover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called Prilosec OTC 20 mg Tablets
Omeprazole Magnesium DR Capsules 20 mg
| Study group | Role | What they receive |
|---|---|---|
| Prilosec 20 mg Tablets | Active comparator | Not described Receives: Drug: Omeprazole |
| Omeprazole Magnesium DR 20 mg Capsules | Experimental | Not described Receives: Drug: Omeprazole |
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 posted11 Jan 2010 (estimated)
- Study startDec 2006
- Primary completionDec 2006
- Study completionMar 2007
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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr IS Gandhi, Principal investigator, Vimta Labs Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01045642
- Sponsor's protocol ID
- OMP/CR/070/0607
- Status last verified
- Jan 2010
- First submitted
- 8 Jan 2010
- Last updated
- 20 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Balanced Randomized,Two-treatment,Two-period,Two-sequence,Single Dose,Crossover Oral Bioequivalence Study of Omeprazole Mg 20mg DR Capsules With Prilosec OTCTM 20mg in 38 Healthy,Adult,Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01045642
- Acronym / sponsor ID
- OMP/CR/070/0607
- Conditions
- Healthy
- Keywords
- Bioequivalence, Omeprazole, Crossover
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 11 Jan 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.
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting conditions.
Detailed description
All study related procedures, restrictions, duration, dates and timings, information on the study formulation and confidentiality of subject data were explained clearly to the volunteers by clinical personnel at the time of obtaining informed consent. Volunteers who signed the consent form and showed"their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prilosec 20 mg Tablets | Active comparator | Drug: Omeprazole |
| Omeprazole Magnesium DR 20 mg Capsules | Experimental | Drug: Omeprazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subjects who provided written informed consent.
- Subjects who were healthy adults within 18-45 years of age (inclusive).
- Body mass index of ≥ 18 kg/m2 and ≤ 25 kglm2 with body weight not less than 50 kg.
- Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of Period-I.
- Had normal ECG, Chest X-ray and vital signs.
Key exclusion criteria (21 listed)
- Subjects incapable of understanding the informed consent.
- Subjects with BP≤90/60 mrn/Hg or BP≥140/90 mrn/Hg
- History of hypersensitivity or idiosyncratic reaction to Omeprazole or any other related drug.
- Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years),diabetes, psychosis or glaucoma will not be eligible for the study
- 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 |
|---|---|---|
| OmeprazoleAlso: Prilosec OTC 20 mg TabletsOmeprazole Magnesium DR Capsules 20 mg | Drug | Omeprazole Magnesium DR 20 mg Capsules, Prilosec 20 mg Tablets |
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 20 Jan 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.
Dr IS Gandhi principal investigator
Vimta Labs Limited
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 Omeprazole in people with Healthy, 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 8 inclusion and 21 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 20 Jan 2010. 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 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 20 Jan 2010.