Healthy VolunteerPhase 1YH16410 DDINCT01992601
A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
A Phase 1 study testing Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) in people with Healthy Volunteer, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration. Total number of subjects is 48. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2012to Jan 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 19 and 27 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
- 1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- 4. Administration of other investigational products within 90 days prior to the first dosing.
- 5. Administration of herbal medicine within 30 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).
- 6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening 7. 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
This clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.
The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.
The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.
- Conditions
- Healthy Volunteer
- Being tested
- Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)
- Keywords
- Drug interaction, Rosuvastatin, Telmisartan, Pharmacokinetic, (Pharmacokinetics and Drug Interaction)
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)Drug
For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period.
For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This arm is consist of 12 subject. Crestor 20mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2. Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) |
| 2 | Experimental | This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Crestor 20mg alone for 6 day during period 2. Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) |
| 3 | Experimental | This arm is consist of 12 subject. Micardis 80mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2. Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) |
| 4 | Experimental | This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Micardis 80mg alone for 6 day during period 2. Receives: Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
AUC τ,ss of Rosuvastatin and Telmisartan
Measured: 72hr
Cmax
Cmax,ss of Rosuvastatin and Telmisartan
Measured: 72hr
Secondary outcomes (7)
AUC
AUC last,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Measured: 72hr
AUC
AUC inf,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Measured: 72hr
Tmax
Tmax,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Measured: 72hr
t1/2
t1/2 of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Measured: 72hr
Cmin
Cmin,ss of Rosuvastatin, N-desmetyl Rosuvastatin and Telmisartan
Measured: 72hr
AUC
AUCτ,ss of N-desmetyl Rosuvastatin
Measured: 72hr
Cmax
Cmax,ss of N-desmetyl Rosuvastatin
Measured: 72hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 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
- NCT01992601
- Sponsor's protocol ID
- YH16410-101
- Acronym
- YH16410 DDI
- Status last verified
- Nov 2013
- First submitted
- 30 Sep 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Son M, Kim Y, Lee D, Roh H, Son H, Guk J, Jang SB, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1147-58. doi: 10.1016/j.clinthera.2014.06.007. Epub 2014 Jul 3.
PubMed 24998012
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multiple-dose, Crossover Study to Investigate the Pharmacokinetic Drug Interaction Between Rosuvastatin and Telmisartan in Healthy Volunteer
- ClinicalTrials.gov ID
- NCT01992601
- Acronym / sponsor ID
- YH16410 DDI / YH16410-101
- Conditions
- Healthy Volunteer
- Keywords
- Drug interaction, Rosuvastatin, Telmisartan, Pharmacokinetic, (Pharmacokinetics and Drug Interaction)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 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 clinical trial is designed to compare the pharmacokinetic characteristics of combination and separate administration of Crestor(Rosuvastatin) and Micardis(Telmisartan). Also investigate drug interaction between separate and combination administration.
Total number of subjects is 48. 4 group(12 for 1 group), 2 period, consecutive 6 day administration, 16 days washout after 6th day of administration.
The subjects of Part 1 take Crestor alone and Crestor+Micardis combination by a cross-over design during 2 each period.
The other subjects of Part 2 take Micardis alone and Crestor+Micardis combination by a cross-over design during 2 each period.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)This arm is consist of 12 subject. Crestor 20mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2. |
| 2 | Experimental | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Crestor 20mg alone for 6 day during period 2. |
| 3 | Experimental | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)This arm is consist of 12 subject. Micardis 80mg alone for 6 day during period 1. Crestor 20mg and Micardis 80mg for 6 day during period 2. |
| 4 | Experimental | Drug: Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)This arm is consist of 12 subject. Crestor 20mg and Micardis 80mg for 6 day during period 1. Micardis 80mg alone for 6 day during period 2. |
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 19 and 27 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 (4 listed)
- 1.History of and clinically significant disease 2.Sitting blood pressure meeting the following criteria at screening: 150 ≤ systolic blood pressure ≤90 (mmHg) and 95 ≤ diastolic blood pressure ≤ 50 (mmHg) amd 100 ≤ Heart rate ≤ 40 3. A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs.
- 4. Administration of other investigational products within 90 days prior to the first dosing.
- 5. Administration of herbal medicine within 30 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).
- 6.Have AST(SGOT) or/and ALT(SGPT) > 3 times of normal upper limit at the time of screening 7. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) 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 |
|---|---|---|
| Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period. For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period. | Drug | 1, 2, 3, 4 |
Primary outcome
AUC
Time frame: 72hr
AUC τ,ss of Rosuvastatin and Telmisartan
Cmax
Time frame: 72hr
Cmax,ss of Rosuvastatin and Telmisartan
7 secondary outcomes
AUC
Time frame: 72hr
AUC
Time frame: 72hr
Tmax
Time frame: 72hr
t1/2
Time frame: 72hr
Cmin
Time frame: 72hr
AUC
Time frame: 72hr
Cmax
Time frame: 72hr
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 25 Nov 2013.
- Derived from this study: PubMed 24998012Son M, Kim Y, Lee D, Roh H, Son H, Guk J, Jang SB, Nam SY, Park K. Pharmacokinetic interaction between rosuvastatin and telmisartan in healthy Korean male volunteers: a randomized, open-label, two-period, crossover, multiple-dose study. Clin Ther. 2014 Aug 1;36(8):1147-58. doi: 10.1016/j.clinthera.2014.06.007. Epub 2014 Jul 3.
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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.
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) in people with Healthy 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 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 25 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?
AUC (time frame: 72hr). 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?
On the ClinicalTrials.gov record for NCT01992601, which also lists 1 linked publication.
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 25 Nov 2013; AzTrials last refreshed its copy on 3 Nov 2026.