HypertensionPhase 1NCT03116516
Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin
A Phase 1 study testing Temisartan/Amlodipine+Rosuvastatin and YHP1604 in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics. 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, Hyperlipidemia
- What is being tested?
- Temisartan/Amlodipine+Rosuvastatin and YHP1604
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2017to 26 May 2017
- 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
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Who cannot join
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers
Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.
Read the detailed description
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
- Conditions
- Hypertension, Hyperlipidemia
- Being tested
- Temisartan/Amlodipine+Rosuvastatin, YHP1604
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temisartan/Amlodipine+RosuvastatinDrug
Also called Twynsta Tab.+Crestor Tab.
All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
YHP1604Drug
Also called FDC
All subjects will receive a single oral dose of YHP1604 administered in the morning.
| Study group | Role | What they receive |
|---|---|---|
| ARM1 | Other | In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22. Receives: Drug: Temisartan/Amlodipine+Rosuvastatin; Drug: YHP1604 |
| ARM2 | Other | In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22. Receives: Drug: Temisartan/Amlodipine+Rosuvastatin; Drug: YHP1604 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast
Cmax, AUClast
Measured: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start21 Apr 2017
- Primary completion26 May 2017
- Study completion26 May 2017
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.
- More trials run by Yuhan CorporationThe sponsor's other registered studies.
- 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
- Model description
- A randomized, open-label, single dose, crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mingul Kim, MD, Principal investigator, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116516
- Sponsor's protocol ID
- YHP1604-102
- Status last verified
- Jan 2019
- First submitted
- 12 Apr 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single Dose, Crossover Clinical Trial to Compare the Safety and Pharmacokinetics of YHP1604 in Comparison to the Co-administration of Telmisartan/Amlodipine and Rosuvastatin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03116516
- Acronym / sponsor ID
- YHP1604-102
- Conditions
- Hypertension, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2017 (actual)
- Primary completion
- 26 May 2017 (actual)
- Study completion
- 26 May 2017 (actual)
- First posted
- 17 Apr 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.
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers
Hypothesis: "YHP1604" and "telmisartan/amlodipine and rosuvastatin" are showing equal pharmacokinetics.
Detailed description
This is a phase 1, open label, single-dose, crossover study to investigate the pharmacokinetics of YHP1604 in comparison to the co-administration of telmisartan/amlodipine and rosuvastatin in healthy male volunteers.
In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22.
In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized, open-label, single dose, crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| ARM1 | Other | Drug: Temisartan/Amlodipine+Rosuvastatin, Drug: YHP1604In ARM1, 30 subjects will be assigned and the subjects will be administered "telmisartan/amlodipine and rosuvastatin" at Day1 and "YHP1604" at Day22. |
| ARM2 | Other | Drug: Temisartan/Amlodipine+Rosuvastatin, Drug: YHP1604In ARM2, 30 subjects will be assigned and the subjects will be administered "YHP1604" at Day1 and "telmisartan/amlodipine and rosuvastatin" at Day22. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
- Who has not suffered from clinically significant disease
- Provision of signed written informed consent
Key exclusion criteria (4 listed)
- History of and clinically significant disease
- A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
- Administration of other investigational products within 3 months prior to the first dosing
- Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs
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 |
|---|---|---|
| Temisartan/Amlodipine+RosuvastatinAlso: Twynsta Tab.+Crestor Tab.All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning. | Drug | ARM1, ARM2 |
| YHP1604Also: FDCAll subjects will receive a single oral dose of YHP1604 administered in the morning. | Drug | ARM1, ARM2 |
Primary outcome
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast
Time frame: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs
Cmax, AUClast
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 16 Jan 2019.
- 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.
Mingul Kim, MD principal investigator
Chonbuk National University Hospital
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 Temisartan/Amlodipine+Rosuvastatin and YHP1604 in people with Hypertension and Hyperlipidemia, run by Yuhan Corporation at 1 site in South Korea.
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 3 inclusion and 4 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 16 Jan 2019. 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 South Korea. 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?
Telmisartan/Amlodipine/Rosuvastatin Cmax, AUClast (time frame: 0 - 72 hrs, 0 - 168 hrs, 0 - 48 hrs). 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 16 Jan 2019.