CKD-828 (80/5mg) Pharmacokinetic Study

Study Overview
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Brief Summary
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A randomized, open-label, single-dose, four-period, two-way, crossover study,

Detailed Description
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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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: CKD-828
* Drug: Telmisartan
* Drug: S-amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 19 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>FDC tablet consisting of Telmisartan 80mg/S-Amlodipine 5mg | Drug: CKD-828<br>* Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily (1arm:2period and 4period, 2arm:1period and 3period)<br>* Other names: Telminuvo;|
| Active Comparator: Combination Therapy<br>Coadministration of Telmisartan 80mg and S-amlodipine 5mg | Drug: Telmisartan<br>* - Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine) (1arm:1period and 3period, 2arm: 2period and 4period)<br>* Other names: Micardis;Drug: S-amlodipine<br>* - S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan) (1arm:1period and 3period, 2arm: 2period and 4period)<br>* Other names: Anydipine s;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. |  | 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. |  | up to 144 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tmax after administration of CKD-828(Fixed Dose Combination) tablet and coadministration of corresponding dose of telmisartan and s-amlodipine. |  | 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. |  | 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. |  | up to 144 hours post dose | 
| Number of participants with adverse events | - Adverse Event monitoring | up to 59days post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, CKD-828, Telmisartan, S-amlodipine, Pharmacokinetic