HypertensionPhase 1NCT01352689
CKD-828(80/2.5mg) Pharmacokinetic Study_2nd
A Phase 1 study testing CKD-828(FDC) and Combination Therapy in people with Hypertension, run by Chong Kun Dang Pharmaceutical.
Trial summary
The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- CKD-828(FDC) and Combination Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to May 2011
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
- Have not any congenital or chronic diseases and medical symptom.
- Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
- Able to participate in the entire trial.
- Signed the informed consent form prior to the study participation.
Who cannot join
- Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
- Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)
- Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
- Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
- Hypersensitivity Telmisartan or Amlodipine.
- SBP<90mmHg, 150mmHg<SBP or DBP<50mmHg, 100mmHg<DBP.
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- Abnormal laboratory result(s): AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit.
- Creatinine Clearance<80mL/min
- Clinically significant cardiovascular system, pulmonary system, liver system, renal system, blood system, nervous system or hyperpotassemia (Past history or present)
- History of drug abuse(sleeping tablet, nucleus action painkiller, an opiate or psychotrope etc the central nervous system drug)or showed a positive for the urine screening exam.
- any abnormal diet which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. drinking grapefruit juice(more than 1L per a day) during 7 weeks prior to the first IP administration.)
- A heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
- Previously donate whole blood within 60 days or component blood within 30 days prior to the first IP administraion.
- Medication within 7 days in the first IP administraion professional medical, medicine, OTC taking
- Participated in the other clinical trials within 60days prior to the first IP administraion.
- An impossible one who participates in clinical trial by investigator's decision
About this study
Official title: Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 80mg and S-Amlodipine 2.5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
- Conditions
- Hypertension
- Being tested
- CKD-828(FDC), Combination Therapy
- Keywords
- CKD-828, Hypertension, Primary Hypertension, Healthy Volunteer, S-Amlodipine, Telmisartan, Amlodipine, Pharmacokinetic, Phase 1
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-828(FDC)Drug
Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
Combination TherapyDrug
Drug: Telmisatan 80mg Tablet, Oral, Once Daily
Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
| Study group | Role | What they receive |
|---|---|---|
| CKD-828(Fixed Dose Combination) | Experimental | Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg Receives: Drug: CKD-828(FDC) |
| Free combination Therapy | Experimental | Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine Receives: Drug: Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
Measured: up to 168 hous postdose
Secondary outcomes (2)
Tmax and t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
Measured: up to 168 hours postdose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: up to 22days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2011
- Study completionMay 2011
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01352689
- Sponsor's protocol ID
- 130HPS11K
- Status last verified
- Apr 2011
- First submitted
- 11 May 2011
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 80mg and S-Amlodipine 2.5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01352689
- Acronym / sponsor ID
- 130HPS11K
- Conditions
- Hypertension
- Keywords
- CKD-828, Hypertension, Primary Hypertension, Healthy Volunteer, S-Amlodipine, Telmisartan, Amlodipine, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 May 2011 (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 purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
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-828(FDC)Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg |
| Free combination Therapy | Experimental | Drug: Combination TherapyCo-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight.
- Have not any congenital or chronic diseases and medical symptom.
- Appropriate for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening).
- Able to participate in the entire trial.
- Signed the informed consent form prior to the study participation.
Key exclusion criteria (16 listed)
- Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administraion.
- Take oriental medicine inside St John's Wort or metabolism of CYP3A4 enzyme or inhibite the CYP enzyme or increase the making drugs(itraconazole, ketoconazole, erythromycine, clarithromycine, telithromycin, HIV protease inhibitor)
- Disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
- Relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
- Hypersensitivity Telmisartan or Amlodipine.
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-828(FDC)Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily | Drug | CKD-828(Fixed Dose Combination) |
| Combination TherapyDrug: Telmisatan 80mg Tablet, Oral, Once Daily Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily | Drug | Free combination Therapy |
Primary outcome
The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
Time frame: up to 168 hous postdose
2 secondary outcomes
Tmax and t1/2 after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets.
Time frame: up to 168 hours postdose
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: up to 22days
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 Jun 2011.
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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 CKD-828(FDC) and Combination Therapy in people with Hypertension, run by Chong Kun Dang Pharmaceutical.
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 16 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 Jun 2011. 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?
The area under the plasma concentration-time curve (AUC) and Cmax after administration of CKD-828(Fixed Dose Combination) tablet and co-administration of corresponding dose of Telmisartan and S-Amlodipine as individual tablets. (time frame: up to 168 hous postdose). 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 Jun 2011.