A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated Fimasartan and Linagliptin.

Detailed Description
-----------------
This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration of Fimasartan and Linagliptin.

Official Title
-----------------
A Randomized, Open-label, Single Dose, 3x3 Partial Replicated Crossover Study to Evaluate the Pharmacokinetics and Safety/Tolerability Between a Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg and Co-administration of Fimasartan 120 mg and Linagliptin 5 mg in Healthy Male Volunteers

Conditions
-----------------
Hypertension, Diabetes

Intervention / Treatment
-----------------
* Drug: Treatment A (Fimasartan, Linagliptin)
* Drug: Treatment B (Fimasartan/Linagliptin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male 19-50 years of age. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol. Medically healthy with no clinically significant medical history. Exclusion Criteria: History or presence of clinically significant medical or psychiatric condition or disease. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV). Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening. Plasma donation within a month prior to the first dose of study drug. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period. | Drug: Treatment A (Fimasartan, Linagliptin)<br>* Co-administration of Fimasartan and Linagliptin<br>Drug: Treatment B (Fimasartan/Linagliptin)<br>* Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg<br>|
| Experimental: Sequence B<br>Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period. | Drug: Treatment A (Fimasartan, Linagliptin)<br>* Co-administration of Fimasartan and Linagliptin<br>Drug: Treatment B (Fimasartan/Linagliptin)<br>* Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg<br>|
| Experimental: Sequency C<br>Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period. | Drug: Treatment A (Fimasartan, Linagliptin)<br>* Co-administration of Fimasartan and Linagliptin<br>Drug: Treatment B (Fimasartan/Linagliptin)<br>* Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of drug in plasma of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration | 
| AUClast | Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin | Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fimasartan, Linagliptin