CKD-828(80/2.5mg) Pharmacokinetic Study_2nd

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-828(FDC)
* Drug: Combination Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-828(Fixed Dose Combination)<br>Single oral dose of a FDC tablet consisting of Telmisatan 80mg/S-Amlodipine 2.5mg | Drug: CKD-828(FDC)<br>* Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily<br>|
| Experimental: Free combination Therapy<br>Co-administration of single oral doses of a 80mg tablet of Telmisatan and a 2.5 mg tablet of S-Amlodipine | Drug: Combination Therapy<br>* Drug: Telmisatan 80mg Tablet, Oral, Once Daily Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | up to 168 hous postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | up to 168 hours postdose | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | up to 22days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Primary Hypertension, Healthy Volunteer, S-Amlodipine, Telmisartan, Amlodipine, Pharmacokinetic, CKD-828, Phase 1