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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

(fimasartan or linagliptin) x 7days

(fimasartan and linagliptin) x 7days

About this trial

This is an interventional other trial for Hypertension focused on measuring Fimasartan

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Part A

Part B

Arm Description

Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days

Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days

Outcomes

Primary Outcome Measures

[Part A] AUC of fimasartan

[Part A] Area under the curve(AUC) of fimasartan in steady state

[Part A] Cmax of fimasartan

[Part A] Cmax of fimasartan in steady state

[Part B] AUC of Linagliptin

[Part B] Area under the curve(AUC) of Linagliptin in Steady State

[Part B] Cmax of linagliptin

[Part B] Cmax of linagliptin in steady state

Secondary Outcome Measures

Full Information

NCT ID

NCT03250052

First Posted

August 10, 2017

Last Updated

January 16, 2018

Sponsor

Boryung Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03250052

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

August 14, 2017 (Actual)

Primary Completion Date

October 13, 2017 (Actual)

Study Completion Date

November 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boryung Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Fimasartan

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Part A

Arm Type

Experimental

Arm Description

Period 1(fimasartan) x 7days - Period 2(fimasartan + linagliptin) x 7days

Arm Title

Part B

Arm Type

Experimental

Arm Description

Period 1(linagliptin) x 7days - Period 2(fimasartan + linagliptin) x 7days

Intervention Type

Drug

Intervention Name(s)

(fimasartan or linagliptin) x 7days

Intervention Description

Part A: fimasartan, Part B: linagliptin

Intervention Type

Drug

Intervention Name(s)

(fimasartan and linagliptin) x 7days

Intervention Description

Part A & Part B: Co-administration of fimasartan and linagliptin

Primary Outcome Measure Information:

Title

[Part A] AUC of fimasartan

Description

[Part A] Area under the curve(AUC) of fimasartan in steady state

Time Frame

0~24 hour after drug administration

Title

[Part A] Cmax of fimasartan

Description

[Part A] Cmax of fimasartan in steady state

Time Frame

0~24 hour after drug administration

Title

[Part B] AUC of Linagliptin

Description

[Part B] Area under the curve(AUC) of Linagliptin in Steady State

Time Frame

0~24 hour after drug administration

Title

[Part B] Cmax of linagliptin

Description

[Part B] Cmax of linagliptin in steady state

Time Frame

0~24 hour after drug administration

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Young-Ran Yoon, PhD

Organizational Affiliation

Kyungpook National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kyungpook National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32546973

Citation

Kang WY, Lee HW, Gwon MR, Cho S, Shim WS, Lee KT, Yang DH, Seong SJ, Yoon YR. A Pharmacokinetic Drug Interaction Between Fimasartan and Linagliptin in Healthy Volunteers. Drug Des Devel Ther. 2020 May 26;14:2101-2111. doi: 10.2147/DDDT.S248205. eCollection 2020.

Results Reference

derived

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

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