Healthy SubjectsPhase 1NCT03319706
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Olmesartan Medoxomil Tablets Under Fed Conditions
A Phase 1 study testing Torrent's Olmesartan Medoxomil Tablets 40 mg and Daiichi Sankyo Inc's Benicar Tablets 40 mg in people with Healthy Subjects, run by Torrent Pharmaceuticals Limited.
Trial summary
Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 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 Subjects
- What is being tested?
- Torrent's Olmesartan Medoxomil Tablets 40 mg and Daiichi Sankyo Inc's Benicar Tablets 40 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Sep 2010
- 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
- Healthy males with age between 18-45 years (both inclusive)
- Weight equal to or more than 50.00 Kgs
- BMI 18.50 - 24.90 Kg/m2
- Healthy as determined by medical history, clinical and laboratory examination performed within 21 days prior to admission day for the first period of the study.
- Must have provided written informed consent for participation in the study in the subject's vernacular language
- In the opinion of the Principal Investigator/Designee, be able to comply with the study procedures and protocol restrictions.
Who cannot join
- Known hypersensitivity or idiosyncratic reaction to Olmesartan, its excipients or similar classes of drugs
- Any evidence of significant abnormalities upon physical or clinical examination
- Sitting blood pressure less than 100/70 mm Hg or more than 140/90 mm Hg and radical pulse rate less than 60 mm Hg or more than 100 mm Hg per minute at the time of screening.
- Laboratory values, which are significantly different from predefined reference ranges and judged clinically significant.
- Any clinically significant abnormality in ECG.
- Any clinically significant abnormality in Chest X-ray (PA view)
Show all 19Show fewer
- Regular use of tobacco or nicotine in significant amount in any form (e.g. use of more than 10 cigarettes a day) or have difficulty in abstaining from [smoking] nicotine use for the duration of the study period.
- History of drug dependence or excessive alcohol intake [subjects who drink more than 2 units per day (30 ml of 40% alcohol) or more than 14 units per week] on a habitual basis, or inability to abstain from alcohol for the duration of study period.
- History or presence of serious gastrointestinal, liver, kidney, heart, lung, neurological or blood disease, diabetes or glaucoma.
- History or presence of any chronic illnesses such as arthritis, asthma, epilepsy, hypertension etc.
- Presence of disease markers of HIV 1 OR 2, Hepatitis B or C Viruses and VDRL.
- Positive result for drug(s) of abuse testing (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opioids) in urine.
- Positive test for alcohol breath analyzer test.
- History and presence of any psychiatric illness.
- History and presence of any illness including allergic skin diseases, allergic asthma and drug-induced allergy, e.g. NSAIDs
- History of significant blood loss (≥ 350 mL) due to any reason, including blood donation within last 12 weeks prior to screening.
- Existence of any surgical or medical condition which in the judgment of Principal Investigator/ Designee might interfere with the absorption, distribution, metabolism or excretion of the study drug, or, is likely to compromise the safety of subject.
- Intake of any enzyme-modifying drugs such as cimetidine, theophylline, benzodiazepines, ranitidine, proton pump inhibitors, erythromycin, diuretics, ketoconazole, anti hypertensive drugs, dopamine agonists, etc within 30 days of study drug administration, or administration/ intake of any prescription or OTC drug including vitamins and natural supplements within 30 days of study drug administration. In such cases, enrolment of the subject in the study will be at the discretion of the Principal Investigator/designee.
- Intake of unusual diet (e.g. low sodium) for two weeks prior to screening and throughout the subject's participation the study. In such case, subject selection will be at the discretion of the Principal investigator/ designee.
About this study
Official title: An Open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose BE of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fed Condition.
Subjects to compare the single dose bioavailability of Torrent's Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 days.
Read the detailed description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.
- Conditions
- Healthy Subjects
- Being tested
- Torrent's Olmesartan Medoxomil Tablets 40 mg, Daiichi Sankyo Inc's Benicar Tablets 40 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Torrent's Olmesartan Medoxomil Tablets 40 mgDrug
Daiichi Sankyo Inc's Benicar Tablets 40 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Torrent's Olmesartan Medoxomil Tablets 40 mg Receives: Drug: Torrent's Olmesartan Medoxomil Tablets 40 mg |
| Reference | Active comparator | Daiichi Sankyo Inc's Benicar Tablets 40 mg Receives: Drug: Daiichi Sankyo Inc's Benicar Tablets 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Measured: pre-dose to 72 hours post dose
AUC
Measured: pre-dose to 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study startAug 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- 34 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
- NCT03319706
- Sponsor's protocol ID
- OLME/10/027
- Status last verified
- Oct 2017
- First submitted
- 19 Oct 2017
- Last updated
- 24 Oct 2017
- 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 24 Oct 2017. 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 of Olmesartan Medoxomil Tablets 40 mg [Torrent,India] Versus Benicar 40 mg Tablets [Daiichi Sankyo Inc., USA] in Healthy Subjects-Fed Condition.
- ClinicalTrials.gov ID
- NCT03319706
- Acronym / sponsor ID
- OLME/10/027
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Torrent Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 24 Oct 2017 (actual)
- 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 Olmesartan Medoxomil Tablets 40 mg and Benicar® 40 mg Tablets of Daiichi Sankyo Inc., USA. Dosing periods of studies were separated by a washout period of 7 days.
Detailed description
An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan Medoxomil Tablets containing Olmesartan Medoxomil 40 mg (Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Benicar® 40 mg Tablets containing Olmesartan Medoxomil 40 mg (Reference, Daiichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed 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 Olmesartan Medoxomil Tablets 40 mgTorrent's Olmesartan Medoxomil Tablets 40 mg |
| Reference | Active comparator | Drug: Daiichi Sankyo Inc's Benicar Tablets 40 mgDaiichi Sankyo Inc's Benicar Tablets 40 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males with age between 18-45 years (both inclusive)
- Weight equal to or more than 50.00 Kgs
- BMI 18.50 - 24.90 Kg/m2
- Healthy as determined by medical history, clinical and laboratory examination performed within 21 days prior to admission day for the first period of the study.
- Must have provided written informed consent for participation in the study in the subject's vernacular language
Key exclusion criteria (19 listed)
- Known hypersensitivity or idiosyncratic reaction to Olmesartan, its excipients or similar classes of drugs
- Any evidence of significant abnormalities upon physical or clinical examination
- Sitting blood pressure less than 100/70 mm Hg or more than 140/90 mm Hg and radical pulse rate less than 60 mm Hg or more than 100 mm Hg per minute at the time of screening.
- Laboratory values, which are significantly different from predefined reference ranges and judged clinically significant.
- Any clinically significant abnormality in ECG.
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 Olmesartan Medoxomil Tablets 40 mg | Drug | Test |
| Daiichi Sankyo Inc's Benicar Tablets 40 mg | Drug | Reference |
Primary outcome
Cmax
Time frame: pre-dose to 72 hours post dose
AUC
Time frame: pre-dose to 72 hours post dose
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 24 Oct 2017.
- 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 Torrent's Olmesartan Medoxomil Tablets 40 mg and Daiichi Sankyo Inc's Benicar Tablets 40 mg in people with Healthy Subjects, 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 19 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 24 Oct 2017. 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 72 hours 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 24 Oct 2017.