CKD-828 (40/5mg) Pharmacokinetic Study

Study Overview
=================
Brief 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.

Official Title
-----------------
Open Label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics of Telmisatan 40mg and S-Amlodipine 5mg as a Fixed Dose Combination Tablet Compared With Combination Therapy in Healthy Volunteers

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: CKD-828
* Drug: Combination Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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. The evidence of acute disease within 28 days prior to the first IP administraion. 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 or DBP<50mmHg. Abnormal laboratory result(s): AST or ALT > 1.25 times of upper limit / Total bilirubin > 1.5 times of upper limit. A drug abuse or 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. Diet(Especially, grapefruit juice-within 7 days prior to the first IP administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s). Donated whole blood within 60 days prior to the first IP administraion. Participated in the other clinical trials within 90days prior to the first IP administraion. Medicine within 10 days prior to the first IP administraion? Does the medication affect this trial. Appropriate for the trial judging from principal investigator.

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

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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 40mg/S-Amlodipine 5mg Intervention | Drug: CKD-828<br>* Drug: Telmisartan 40mg + S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily<br>|
| Active Comparator: Free combination Therapy<br>Co-administration of single oral doses of a 40mg tablet of Telmisatan and a 5 mg tablet of S-Amlodipine | Drug: Combination Therapy<br>* Drug: Telmisartan 40mg Tablet, Oral, Once Daily Drug: S-amlodipine 5mg Tablet, Oral, Once Daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 hours postdose | 
| The area under the plasma concentration-time curve (AUC) 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 | 

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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telmisartan, CKD-828, Hypertension, Primary Hypertension, Healthy Volunteer, S-Amlodipine, Amlodipine, Pharmacokinetic, Phase 1