Study to Evaluate the Safety and PK of LODIENT Tablet 80/2.5mg in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
A randomized, open label, single dose, 2-sequence, 4-period, cross-over phase I clinical trial to compare and evaluate the safety and pharmacokinetics after oral administration of LodienT tablet 80/2.5mg(telmisartan/s-amlodipine) and TWINSTA tablet 80/5mg(telmisartan/amlodipine) in healthy adult volunteers.

Detailed Description
-----------------
Amlodipine is a drug which belongs to calcium channel blockers (CCBs) and is used to treat hypertension. The molecule contains one chiral carbon atom and exists as a racemic mixture. As only the S-enantiomer of amlodipine [S-amlodipine] shows the CCB effect and R-amlodipine is responsible for the development of peripheral edema, purifying S-amlodipine can reduce the incidences of peripheral edema and other side effects.

Official Title
-----------------
A Randomized, Open Label, Single Dose, 2-sequence, 4-period, Cross-over Phase I Clinical Trial to Compare and Evaluate the Safety and PK After Oral Administration of LodienT Tablet 80/2.5mg and TWYNSTA Tablet 80/5mg in Healthy Adult Volunteers

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

Intervention / Treatment
-----------------
* Drug: Twynsta
* Drug: LodineT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers aged more than 19 years old Subject does not have congenital or chronic disease and is without pathologic symptom or finding on medical exam. Subject was determined eligible according to the results of clinical laboratory tests like serum test, hematologic test, blood chemistry test, urine test etc. and vital signs, electrocardiography, physical exam etc. performed during the screening exam. 90mmHg≤SBP≤139mmHg and 60mmHg≤DBP≤89mmHg) Body mass index (BMI) of 18-30kg/m2 Willing and able to provide written informed consent Exclusion Criteria: Administration of other drug than can modulate metabolic enzyme within 1 months prior to the scrrening day. Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs Continued excessive use of alcohol(alcohol>21 cups/day) and severe heavy smoker (cigarette > 20 cigarettes per day) Administration of other investigational products within 6 months prior to the first dosing Subject with the following conditions in laboratory test : AST(sGOT) or ALT(sGPT) > Upper normal limit × 1.5 Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days Subject who take a medication that affect to the pharmacokinetics of drug within 10 days Subject with decision of non-participation through investigator's review

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

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 |
| --- | --- |
| Active Comparator: Reference<br>TWYNSTA Tablet 80/5mg(Telmisartan/Amlodipine) | Drug: Twynsta<br>* Manufactured by Boehringer Ingelheim<br>|
| Experimental: Test<br>LodienT Tablet 80/2.5mg(Telmisartan/S-amlodipine) | Drug: LodineT<br>* •Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt |  | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr | 
| Cmax |  | 0(pre-dose), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48 and 72hr |