HypertensionPhase 1NCT02789475
DP-R212 Pharmacokinetic Study
A Phase 1 study testing Amlodipine and Rosuvastatin in people with Hypertension and Hyperlipidemias, run by Alvogen Korea at 1 site in South Korea.
Trial summary
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hyperlipidemias
- What is being tested?
- Amlodipine and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2016to Jul 2016
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18-29
- signed the informed consent form prior to the study participation
Who cannot join
- Clinically significant disease
- Previously donate whole blood within 60 days or component blood within 14 days
- Clinically significant allergic disease
- Taken IP in other trial within 90 days
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Inha university hospital
Jung-gu, Incheon, 400-711
Chul woo Kim, Ph.D., cwkim1805@inha.ac.kr
About this study
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.
- Conditions
- Hypertension, Hyperlipidemias
- Being tested
- Amlodipine, Rosuvastatin
- Medical subject headings
- Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Amlodipine administration
RosuvastatinDrug
Rosuvastatin administration
| Study group | Role | What they receive |
|---|---|---|
| amplodipine group | Experimental | Amlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days Receives: Drug: Amlodipine; Drug: Rosuvastatin |
| rosuvastatin group | Experimental | Rosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days Receives: Drug: Amlodipine; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss of Amlodipine and Rosuvastatin
Measured: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Cmax,ss of Amlodipine and Rosuvastatin
Measured: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chul woo Kim, Ph.D., Principal investigator, Inha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789475
- Sponsor's protocol ID
- DP-CTR-212-I-01
- Status last verified
- May 2016
- First submitted
- 23 May 2016
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DP-R212 Pharmacokinetic Study
- ClinicalTrials.gov ID
- NCT02789475
- Acronym / sponsor ID
- DP-CTR-212-I-01
- Conditions
- Hypertension, Hyperlipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 3 Jun 2016 (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.
An open-label, multiple-dose study to evaluate the pharmacokinetic drug-drug interaction of amlodipine and rosuvastatin in healthy adult male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amplodipine group | Experimental | Drug: Amlodipine, Drug: RosuvastatinAmlodipine for 8 days and Amlodipine+Rosuvastatin for 5 days |
| rosuvastatin group | Experimental | Drug: Amlodipine, Drug: RosuvastatinRosuvastatin for 5 days and Amlodipine+Rosuvastatin for 8 days |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 18-29
- signed the informed consent form prior to the study participation
Key exclusion criteria (5 listed)
- Clinically significant disease
- Previously donate whole blood within 60 days or component blood within 14 days
- Clinically significant allergic disease
- Taken IP in other trial within 90 days
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
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 |
|---|---|---|
| AmlodipineAmlodipine administration | Drug | amplodipine group, rosuvastatin group |
| RosuvastatinRosuvastatin administration | Drug | amplodipine group, rosuvastatin group |
Primary outcome
AUCτ,ss of Amlodipine and Rosuvastatin
Time frame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Cmax,ss of Amlodipine and Rosuvastatin
Time frame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 4
A Clinical Study of MK-7962 in Chinese Participants With Pulmonary Arterial Hypertension (MK-7962-022)
Hypertension, Pulmonary
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Not yet recruitingObservational study
Real-World Validation for Less-Disturbing Ambulatory Blood Pressure Monitoring (ABPM) in Malaysia Using Huawei Wearables
Hypertension
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.
Chul woo Kim, Ph.D. principal investigator
Inha 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 Amlodipine and Rosuvastatin in people with Hypertension and Hyperlipidemias, run by Alvogen Korea 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jun 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chul woo Kim, Ph.D. (82-92-890-1168, cwkim1805@inha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUCτ,ss of Amlodipine and Rosuvastatin (time frame: 0,0.5,1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hr). 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 3 Jun 2016; AzTrials last refreshed its copy on 29 Oct 2026.