HypertensionPhase 1CKD-828NCT02358824
CKD-828 (80/5mg) Pharmacokinetic Study
A Phase 1 study testing CKD-828, Telmisartan and S-amlodipine in people with Hypertension, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A randomized, open-label, single-dose, four-period, two-way, crossover study, Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-828, Telmisartan and S-amlodipine
- 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
- Feb 2015to Jun 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A healthy volunteer over 20 years old
- More than 50kg and within 20% of ideal body weight
- No any congenital or chronic diseases and medical symptom
- Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
- Signed the informed consent form prior to the study participation.
Who cannot join
- History of relevant hypersensitivity against drug
- Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
- Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin > 1.5*ULN)
- SBP <90mmHg or SBP >150mmHg
- DBP <50mmHg or DBP >100mmHg
- Creatinine clearance <80mL/min
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- A Disease(ex.inflammatory intestinal disease, gastric or duodenal ulcer ,hepatic disease history , gastro-intestinal surgery except for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug
- The evidence of severe attack or acute disease or surgical intervention within 28 days prior to the first IP administration.
- A drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or regular alcohol consumer(more than 21 units/week) or a heavy smoker(more than 10 cigarettes per a day)
- Taking ETC medicine or oriental medicine within 14days or Taking OTC medicine within 7days prior to the first IP administration
- Abnormal diet(Especially, grapefruit juice within 7 days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Hospital
Daegu, Samdeok-dong, 2-ga 50, Samdeok-dong, 2-ga 50 Jung-gu, 700-721
About this study
Official title: A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
A randomized, open-label, single-dose, four-period, two-way, crossover study,
Read the detailed description
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.
- Conditions
- Hypertension
- Being tested
- CKD-828, Telmisartan, S-amlodipine
- Keywords
- Hypertension, CKD-828, Telmisartan, S-amlodipine, Pharmacokinetic
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-828Drug
Also called Telminuvo
Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
(1arm:2period and 4period, 2arm:1period and 3period)
TelmisartanDrug
Also called Micardis
- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period)
S-amlodipineDrug
Also called Anydipine s
- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period)
| Study group | Role | What they receive |
|---|---|---|
| CKD-828(Fixed Dose Combination) | Experimental | FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg Receives: Drug: CKD-828 |
| Combination Therapy | Active comparator | Coadministration of Telmisartan 80mg and S-amlodipine 5mg Receives: Drug: Telmisartan; Drug: S-amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Measured: up to 144 hours post dose
AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Measured: up to 144 hours post dose
Secondary outcomes (4)
Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Measured: up to 144 hours post dose
t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Measured: up to 144 hours post dose
AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Measured: up to 144 hours post dose
Number of participants with adverse events
- Adverse Event monitoring
Measured: up to 59days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionJun 2015
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.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Young-Ran Yoon, Principal investigator, Kyungpook National University Hospital Clinical Trial Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358824
- Sponsor's protocol ID
- 130BE15002
- Acronym
- CKD-828
- Status last verified
- Jul 2015
- First submitted
- 4 Feb 2015
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Compare the Pharmacokinetics and Safety of CKD-828(Telmisartan 80mg/S-amlodipine 5mg Combination Tablet) to Coadministration of Telmisartan 80mg and S-amlodipine 5mg in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02358824
- Acronym / sponsor ID
- CKD-828 / 130BE15002
- Conditions
- Hypertension
- Keywords
- Hypertension, CKD-828, Telmisartan, S-amlodipine, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Feb 2015 (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 randomized, open-label, single-dose, four-period, two-way, crossover study,
Detailed description
A randomized, open-label, single-dose, four-period, two-way, crossover study to compare the pharmacokinetics and safety CKD-828 (Fixed Dose Combination Tablet) to coadministration telmisartan and s-amlodipine in health volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD-828(Fixed Dose Combination) | Experimental | Drug: CKD-828FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg |
| Combination Therapy | Active comparator | Drug: Telmisartan, Drug: S-amlodipineCoadministration of Telmisartan 80mg and S-amlodipine 5mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A healthy volunteer over 20 years old
- More than 50kg and within 20% of ideal body weight
- No any congenital or chronic diseases and medical symptom
- Appropriate for the study from examination(laboratory test, ECG etc.) within 4weeks prior to the first IP administration
- Signed the informed consent form prior to the study participation.
Key exclusion criteria (11 listed)
- History of relevant hypersensitivity against drug
- Clinical significant disease or medical history (ex. hepato/cholangio, cardio, endo, hemato, onco, CNS etc.)
- Active liver disease or abnormal laboratory result (AST or ALT or Total bilirubin > 1.5*ULN)
- SBP <90mmHg or SBP >150mmHg
- DBP <50mmHg or DBP >100mmHg
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 |
|---|---|---|
| CKD-828Also: TelminuvoTelmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period) | Drug | CKD-828(Fixed Dose Combination) |
| TelmisartanAlso: Micardis- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period) | Drug | Combination Therapy |
| S-amlodipineAlso: Anydipine s- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period) | Drug | Combination Therapy |
Primary outcome
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: up to 144 hours post dose
AUClast after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: up to 144 hours post dose
4 secondary outcomes
Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: up to 144 hours post dose
t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: up to 144 hours post dose
AUCinf after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine.
Time frame: up to 144 hours post dose
Number of participants with adverse events
Time frame: up to 59days post dose
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 8 Jul 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.
Young-Ran Yoon principal investigator
Kyungpook National University Hospital Clinical Trial Center
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 CKD-828, Telmisartan and S-amlodipine in people with Hypertension, run by Chong Kun Dang Pharmaceutical 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 5 inclusion and 11 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 8 Jul 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?
Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. (time frame: up to 144 hours post dose). 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 8 Jul 2015.