Healthy Male VolunteerPhase 1NCT02233218

The Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

A Phase 1 study testing Telmisartan, Amlodipine and Rosuvastatin in people with Healthy Male Volunteer, run by Yuhan Corporation at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the pharmacokinetic Drug-drug interaction Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Male Volunteer
What is being tested?: Telmisartan, Amlodipine and Rosuvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteSouth Korea
Study dates: Jul 2014to Jan 2015
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male volunteers aged 19 to 50
Participant who has a body weight that is >=55kg(male) and body mass index (BMI) level that is 18~30
Provision of signed written informed consent

Who cannot join

History of clinically significant disease
History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
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 2 months prior to the first dosing.
Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week 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)
Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to the reasons including laboratory test results, ECGs, or vital signs.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Dong-A university hospital
Pusan

Other trials in South Korea

About this study

Official title: A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers

To investigate the pharmacokinetic Drug-drug interaction

Read the detailed description

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Conditions: Healthy Male Volunteer
Being tested: Telmisartan, Amlodipine, Rosuvastatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TelmisartanDrug
AmlodipineDrug
RosuvastatinDrug

Study groups in NCT02233218
Study group	Role	What they receive
telmisartan, Amlodipine, Rosuvastatin	Experimental	This arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin
Telmisartan, Amlodipine, Rosuvastatin	Experimental	This arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine
Measured: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
Measured: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Secondary outcomes (6)

Time of peak concentration in steady state of Telmisartan and Amlodipine
Measured: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
Measured: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin
Measured: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Jan 2015

First posted8 Sep 2014 (estimated)
Study startJul 2014
Primary completionOct 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy Male VolunteerStudies 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: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02233218
Sponsor's protocol ID: YH22189-101
Status last verified: Feb 2015
First submitted: 26 Aug 2014
Last updated: 18 Feb 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Male Volunteer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label, Non-randomized, Two-cohort, Single-sequence, Crossover Study to Investigate the Pharmacokinetic Drug-drug Interaction and Safety of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02233218
Acronym / sponsor ID: YH22189-101
Conditions: Healthy Male Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Oct 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 8 Sep 2014 (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.

To investigate the pharmacokinetic Drug-drug interaction

Detailed description

The purpose of this study is to investigate the pharmacokinetic Drug-Drug(telmisartan, amlodipine and/ or rosuvastatin) interaction and safety in healthy male volunteers.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
telmisartan, Amlodipine, Rosuvastatin	Experimental	Drug: Telmisartan, Drug: Amlodipine, Drug: RosuvastatinThis arm is consist of 40 subjects. Telmisartan80mg + Amlodipine 10mg 9 days, Telmisartan80mg + Amlodipine 10mg , Rosuvastatin 20mg 5days Total 14days administration of investigational products to healthy male volunteers
Telmisartan, Amlodipine, Rosuvastatin	Experimental	Drug: Telmisartan, Drug: Amlodipine, Drug: RosuvastatinThis arm is consist of 20 subjects. Rosuvastatin 20mg 5 days, Rosuvastatin 20mg , Telmisartan80mg + Amlodipine 10mg 9days, Total 14days administration of investigational products to healthy male volunteers

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy male volunteers aged 19 to 50
Participant who has a body weight that is >=55kg(male) and body mass index (BMI) level that is 18~30
Provision of signed written informed consent

Key exclusion criteria (6 listed)

History of clinically significant disease
History of clinically significant hypersensitivity or hypersensitivity reactions to drugs and other medications (aspirin, antibiotics, etc.), including components such as Telmisartan, Rosuvastatin and Amlodipine
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 2 months prior to the first dosing.
Administration of herbal medicine within 2 weeks or administration of ethical drugs within 2 weeks or administration of over-the-counter (OTC) drugs within 1 week 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
Telmisartan	Drug	Telmisartan, Amlodipine, Rosuvastatin, telmisartan, Amlodipine, Rosuvastatin
Amlodipine	Drug	Telmisartan, Amlodipine, Rosuvastatin, telmisartan, Amlodipine, Rosuvastatin
Rosuvastatin	Drug	Telmisartan, Amlodipine, Rosuvastatin, telmisartan, Amlodipine, Rosuvastatin

Primary outcome

Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine
Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of Rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

6 secondary outcomes

Time of peak concentration in steady state of Telmisartan and Amlodipine
Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Telmisartan and Amlodipine
Time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Area under the plasma/serum/blood drug concentration-time curve in steady-state of N- desmethyl rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Maximum concentration of drug in plasma/serum/blood in steady-state of N- desmethyl rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Time of peak concentration in steady state of rosuvastatin and N- desmethyl rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)
Minimum concentration of drug in plasma/serum/blood in steady-state of Rosuvastatin and N- desmethyl rosuvastatin
Time frame: 0h~24hr at Day 5 (when is expected the steady state of Rosuvastatin) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)

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 18 Feb 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.

Minkgyu Park, Ph.D, M.D. principal investigator

Dong-A university hospital of Korea

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 Telmisartan, Amlodipine and Rosuvastatin in people with Healthy Male Volunteer, 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 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 18 Feb 2015. 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?

Area under the plasma/serum/blood drug concentration-time curve in steady-state of Telmisartan and Amlodipine (time frame: 0h~24hr at Day 9 (when is expected the steady state of Telmisartan and Amlodipine) and 0~24hr at Day 14 (when is expected the steady state of Telmisartan, Amlodipine and Rosuvastatin)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02233218.

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 18 Feb 2015.