HealthyPhase 1NCT02079506
Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin
A Phase 1 study testing Candesartan and Rosuvastatin in people with Healthy, run by Alvogen Korea at 1 site in South Korea.
Trial summary
The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Candesartan and Rosuvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Feb 2014
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers af aged between 20 years to 45 years
- Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
- Eligible subjects with acceptable medical history and physical examination
Who cannot join
- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Jung-gu, Daejeon, 301-721
About this study
Official title: An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers
The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.
- Conditions
- Healthy
- Being tested
- Candesartan, Rosuvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
RosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: Candesartan |
| Treatment B | Experimental | Not described Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCτ,ss of candesartan
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Measured: 22 points
Cmax,ss of candesartan
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Measured: 22 points
AUCτ,ss of rosuvastatin
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Measured: 28 points
Cmax,ss of rosuvastatin
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Measured: 28 points
Secondary outcomes (6)
tmax,ss of candesartan
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Measured: 22 points
CLss/F of candesartan
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Measured: 22 points
Cmin,ss of candesartan
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Measured: 22 points
tmax,ss of rosuvastatin
0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Measured: 28 points
CLss/F of rosuvastatin
0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Measured: 28 points
Cmin,ss of rosuvastatin
0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Measured: 28 points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alvogen Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JangHee Hong, PhD., Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079506
- Sponsor's protocol ID
- DP-CTR208-I-01
- Status last verified
- Mar 2014
- First submitted
- 4 Mar 2014
- Last updated
- 5 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02079506
- Acronym / sponsor ID
- DP-CTR208-I-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alvogen KoreaIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 5 Mar 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.
The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan 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 |
|---|---|---|
| Treatment A | Experimental | Drug: Candesartan |
| Treatment B | Experimental | Drug: Rosuvastatin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers af aged between 20 years to 45 years
- Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
- Eligible subjects with acceptable medical history and physical examination
Key exclusion criteria (1 listed)
- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs
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 |
|---|---|---|
| Candesartan | Drug | Treatment A |
| Rosuvastatin | Drug | Treatment B |
Primary outcome
AUCτ,ss of candesartan
Time frame: 22 points
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
Cmax,ss of candesartan
Time frame: 22 points
0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h
AUCτ,ss of rosuvastatin
Time frame: 28 points
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
Cmax,ss of rosuvastatin
Time frame: 28 points
0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h
6 secondary outcomes
tmax,ss of candesartan
Time frame: 22 points
CLss/F of candesartan
Time frame: 22 points
Cmin,ss of candesartan
Time frame: 22 points
tmax,ss of rosuvastatin
Time frame: 28 points
CLss/F of rosuvastatin
Time frame: 28 points
Cmin,ss of rosuvastatin
Time frame: 28 points
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 Mar 2014.
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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.
JangHee Hong, PhD. principal investigator
Chungnam National 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 Candesartan and Rosuvastatin in people with Healthy, 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 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 5 Mar 2014. 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?
AUCτ,ss of candesartan (time frame: 22 points). 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 5 Mar 2014.