A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

Detailed Description
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This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Official Title
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A Phase I Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

Conditions
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Hypertension

Intervention / Treatment
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* Drug: (fimasartan or linagliptin) x 7days
* Drug: (fimasartan and linagliptin) x 7days


Participation Criteria
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Eligibility Criteria
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1. Inclusion Criteria (Total: 5): 19-50 year-old healthy male. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2 Subject who has no clinically significant medical history. Subject whose informed consent is obtained and who is willing to comply with protocol. 2. Exclusion Criteria (Total: 19): Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or < 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or < 70mmHg Upper Limits of Normal x 1.5 < Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin Creatinine clearance(CrCl) < 80mL/min (using Cockcroft-Gault formula) Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL) Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 50 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days | Drug: (fimasartan or linagliptin) x 7days<br>* Part A: fimasartan, Part B: linagliptin<br>Drug: (fimasartan and linagliptin) x 7days<br>* Part A & Part B: Co-administration of fimasartan and linagliptin<br>|
| Experimental: Part B<br>Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days | Drug: (fimasartan or linagliptin) x 7days<br>* Part A: fimasartan, Part B: linagliptin<br>Drug: (fimasartan and linagliptin) x 7days<br>* Part A & Part B: Co-administration of fimasartan and linagliptin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| [Part A] AUC of fimasartan | [Part A] Area under the curve(AUC) of fimasartan in steady state | 0 24 hour after drug administration | 
| [Part A] Cmax of fimasartan | [Part A] Cmax of fimasartan in steady state | 0 24 hour after drug administration | 
| [Part B] AUC of Linagliptin | [Part B] Area under the curve(AUC) of Linagliptin in Steady State | 0 24 hour after drug administration | 
| [Part B] Cmax of linagliptin | [Part B] Cmax of linagliptin in steady state | 0 24 hour after drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan