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

Primary Purpose

Hypertension, Diabetes

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Treatment A (Fimasartan, Linagliptin)
Treatment B (Fimasartan/Linagliptin)
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male 19-50 years of age.
  2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
  3. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.
  4. Medically healthy with no clinically significant medical history.

Exclusion Criteria:

  1. History or presence of clinically significant medical or psychiatric condition or disease.
  2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
  3. Seated blood pressure is less than 100/55 mmHg or greater than 140/100 mmHg at screening.
  4. Plasma donation within a month prior to the first dose of study drug.
  5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sequence A

Sequence B

Sequency C

Arm Description

Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.

Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.

Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.

Outcomes

Primary Outcome Measures

Cmax
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
AUClast
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin

Secondary Outcome Measures

Full Information

First Posted
July 25, 2018
Last Updated
February 3, 2020
Sponsor
Boryung Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03609294
Brief Title
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
June 30, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes
Keywords
Fimasartan, Linagliptin

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Period 1(Treatment A) - Period 2(Treatment A) - Period 3(Treatment B) There will be a washout of 35 days between the each period.
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Period 1(Treatment A) - Period 2(Treatment B) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Arm Title
Sequency C
Arm Type
Experimental
Arm Description
Period 1(Treatment B) - Period 2(Treatment A) - Period 3(Treatment A) There will be a washout of 35 days between the each period.
Intervention Type
Drug
Intervention Name(s)
Treatment A (Fimasartan, Linagliptin)
Intervention Description
Co-administration of Fimasartan and Linagliptin
Intervention Type
Drug
Intervention Name(s)
Treatment B (Fimasartan/Linagliptin)
Intervention Description
Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
Primary Outcome Measure Information:
Title
Cmax
Description
Maximum concentration of drug in plasma of Fimasartan, Linagliptin
Time Frame
Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration
Title
AUClast
Description
Area under the plasma drug concentration-time curve over the time interval from 0 to the last observed plasma concentration of Fimasartan, Linagliptin
Time Frame
Fimasartan: 0-48 hours after administration, Linagliptin: 0-72 hours after administration

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Sang Yu, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Dahak-ro
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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