Dyslipidemia & HypertensionPhase 1NCT01975961
PK Study of Telmisartan/Rosuvastatin FDC Compared to Combination of Telmisartan and Rosuvastatin
A Phase 1 study testing Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC in people with Dyslipidemia & Hypertension, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia & Hypertension
- What is being tested?
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Sep 2013
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects
Who cannot join
- History of and clinically significant disease
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥ Heart rate ≤ 40
- 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 90 days prior to the first dosing.
- Administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
- Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening
- Volunteers considered not eligible for the clinical trial by the investigator (study doctor) 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, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
This is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
- Conditions
- Dyslipidemia & Hypertension
- Being tested
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC
- Medical subject headings
- Dyslipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDCDrug
For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet.
| Study group | Role | What they receive |
|---|---|---|
| FDC YH16410 | Experimental | Drug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg).
Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC |
| Co-administration | Active comparator | Drug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg).
Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments
Measured: 0~72hr, 17points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dyslipidemia & 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975961
- Sponsor's protocol ID
- YH16410-102
- Status last verified
- Oct 2013
- First submitted
- 20 Oct 2013
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-dose, 2-way Cross-over Study to Compare the Safety and the Pharmacokinetic Characteristics of the Co-administration of Telmisartan and Rosuvastatin and YH16410 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01975961
- Acronym / sponsor ID
- YH16410-102
- Conditions
- Dyslipidemia & Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Nov 2013 (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 is a 2 by 2 cross-over study to evaluate pharmacokinetics of telmisartan and rosuvastatin FDC compared to reference telmisartan and rosuvastatin coadministered in two groups enrolling healthy adult male and female subjects under fasting conditions.
Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of telmisartan/rosuvastatin FDC or telmisartan and rosuvastatin co-administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time.
The two treatment periods will be separated by a washout period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDC YH16410 | Experimental | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDCDrug: Test treatment: FDC YH16410 (Telmisartan 80mg/ Rosuvastatin 20mg). Subjects will receive single oral dose of 1 tablet of FDC containing Telmisartan 80mg and Rosuvastatin 20mg in fasted state |
| Co-administration | Active comparator | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDCDrug: Reference Treatment: Co-administration(Telmisartan 80mg and Rosuvastatin 20mg). Subjects will receive 1 x Telmisartan 80mg with 1 x Rosuvastatin 20mg tablet administered orally in fasted state as a single dose |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female aged 20 to 50 with a body mass index(BMI) between 18.5 and 25 kg/m2
- Acceptable medical history, physical examination, laboratory tests and EKG, during screening
- Provision of signed written informed consent 20~50 yrs old, healthy Korean Subjects
Key exclusion criteria (7 listed)
- History of and clinically significant disease
- Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 65 (mmHg) amd 100 ≥ Heart rate ≤ 40
- 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 90 days prior to the first dosing.
- Administration of herbal medicine within 28 days or administration of ethical drugs within 14 days or administration of over-the-counter (OTC) drugs within 7 days prior to the first dosing of the investigational product (if the investigator (study doctor) determines that the person meets other criteria appropriately, the relevant person may participate in the study).
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 |
|---|---|---|
| Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDCFor co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet. | Drug | Co-administration, FDC YH16410 |
Primary outcome
plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments
Time frame: 0~72hr, 17points
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 5 Nov 2013.
Related trials for Dyslipidemia & Hypertension
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruiting
Multimodal AI-Driven Out-of-Hospital Management for Hypertension and Cardiometabolic Risk
Hypertension, Hyperglycemia
RecruitingObservational study
Observational Study for the Characterisation of Patients Affected by Any Type of Diabetes and Endocrine Disorders
Diabetes, Metabolic Disorders
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.
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 Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC in people with Dyslipidemia & Hypertension, 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 7 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 5 Nov 2013. 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?
plasma pharmacokinetic parameters for telmisartan and rosuvastatin in relevant treatments (time frame: 0~72hr, 17points). 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 5 Nov 2013.