Hypertension and DyslipidemiaPhase 1NCT02933658
Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
A Phase 1 study testing Telmisartan, Amlodipine and Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd..
Trial summary
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers Read more about this study
- Who is it for?
- Ages 19 to 49 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension and Dyslipidemia
- What is being tested?
- Telmisartan, Amlodipine and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 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 49 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male who are ≥19, <50 years old
- Man who weights over 55kg and whose BMI is 18~30(kg/m2)
- Man who doesn't have any chronic disease or history of disease
Who cannot join
- man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry
About this study
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
- Conditions
- Hypertension and Dyslipidemia
- Being tested
- Telmisartan, Amlodipine, Rosuvastatin
- Medical subject headings
- Hypertension, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
AmlodipineDrug
RosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Reference1 | Experimental | single(Reference1) -> combination(Reference1+Reference2) Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin |
| Reference2 | Experimental | single(Reference2) -> combination(Reference1+Reference2) Receives: Drug: Telmisartan; Drug: Amlodipine; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of Reference 1
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 1
Measured: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 2
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 2
Measured: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension and DyslipidemiaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02933658
- Sponsor's protocol ID
- DW-1501-P101
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multiple Oral Dosing to Evaluate the Safety and the Pharmacokinetic Drug-drug Interaction of Telmisartan/Amlodipine and Rosuvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02933658
- Acronym / sponsor ID
- DW-1501-P101
- Conditions
- Hypertension and Dyslipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- First posted
- 14 Oct 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.
A non-randomized, two-arm, single-sequence, crossover, open label, multiple oral dosing clinical trial to evaluate the safety and the pharmacokinetic drug-drug interaction of Telmisartan/Amlodipine and Rosuvastatin in healthy male volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference1 | Experimental | Drug: Telmisartan, Drug: Amlodipine, Drug: Rosuvastatinsingle(Reference1) -> combination(Reference1+Reference2) |
| Reference2 | Experimental | Drug: Telmisartan, Drug: Amlodipine, Drug: Rosuvastatinsingle(Reference2) -> combination(Reference1+Reference2) |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male who are ≥19, <50 years old
- Man who weights over 55kg and whose BMI is 18~30(kg/m2)
- Man who doesn't have any chronic disease or history of disease
Key exclusion criteria (1 listed)
- man who has or had any clinically relevant disease of liver, kidney, nervous/respiratory/musculoskeletal/cardiovascular/hemato-oncology system or neuropsychiatry
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 | Reference1, Reference2 |
| Amlodipine | Drug | Reference1, Reference2 |
| Rosuvastatin | Drug | Reference1, Reference2 |
Primary outcome
AUC of Reference 1
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 1
Time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
AUC of Reference 2
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
Cmax of Reference 2
Time frame: 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24hour
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 14 Oct 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telmisartan, Amlodipine and Rosuvastatin in people with Hypertension and Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd..
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 1 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 of Reference 1 (time frame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24hour). 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?
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 14 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.