HypertensionPhase 1NCT02504606
Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
A Phase 1 study testing Besylsartan and Amosartan in people with Hypertension, run by Huons Co., Ltd..
Trial summary
This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Besylsartan and Amosartan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Oct 2014
- 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 19 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) between 18 and 30
- Healthy as determined by a responsible physician
Who cannot join
- History of clinically significant disease
- Any chronic disease
- Creatine clearance less than 50ml/min
- Hypotension (100mmHg/60mmHg)
- Treatment of barbital type drug within 1 month
- Administration of herbal medicine within 7 days
About this study
Official title: A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.
- Conditions
- Hypertension
- Being tested
- Besylsartan, Amosartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BesylsartanDrug
Amlodipin besylate 6.944mg+Losartan K 100mg
AmosartanDrug
Amlodipin besylate 7.841mg+Losartan K 100mg
| Study group | Role | What they receive |
|---|---|---|
| Besylsartan | Experimental | amlodipine besylate 6.944mg+losartan K 100mg Receives: Drug: Besylsartan |
| Amosartan | Active comparator | amlodipine besylate 7.841mg+losartan K 100mg Receives: Drug: Amosartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in blood concentration of Amlodipine
Detect the change of blood concentration of Amlodipine by LC-MS/MS
Measured: 144 hour
Change from baseline in blood concentration of Losartan
Detect the change of blood concentration of Losartan by LC-MS/MS
Measured: 10 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504606
- Sponsor's protocol ID
- HU-009-01
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Besylsartan Tablet in Healthy Male Subject
- ClinicalTrials.gov ID
- NCT02504606
- Acronym / sponsor ID
- HU-009-01
- Conditions
- Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Jul 2015 (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 clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Besylsartan | Experimental | Drug: Besylsartanamlodipine besylate 6.944mg+losartan K 100mg |
| Amosartan | Active comparator | Drug: Amosartanamlodipine besylate 7.841mg+losartan K 100mg |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body Mass Index (BMI) between 18 and 30
- Healthy as determined by a responsible physician
Key exclusion criteria (6 listed)
- History of clinically significant disease
- Any chronic disease
- Creatine clearance less than 50ml/min
- Hypotension (100mmHg/60mmHg)
- Treatment of barbital type drug within 1 month
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 |
|---|---|---|
| BesylsartanAmlodipin besylate 6.944mg+Losartan K 100mg | Drug | Besylsartan |
| AmosartanAmlodipin besylate 7.841mg+Losartan K 100mg | Drug | Amosartan |
Primary outcome
Change from baseline in blood concentration of Amlodipine
Time frame: 144 hour
Detect the change of blood concentration of Amlodipine by LC-MS/MS
Change from baseline in blood concentration of Losartan
Time frame: 10 hour
Detect the change of blood concentration of Losartan by LC-MS/MS
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 22 Jul 2015.
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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 Besylsartan and Amosartan in people with Hypertension, run by Huons Co., Ltd..
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 2 inclusion and 6 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 22 Jul 2015. 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?
Change from baseline in blood concentration of Amlodipine (time frame: 144 hour). 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 22 Jul 2015.