NCT03609294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P75+ for phase_1 hypertension

Timeline
Completed

Started Jul 2018

Typical duration for phase_1 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

February 5, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

July 25, 2018

Last Update Submit

February 3, 2020

Conditions

HypertensionDiabetes

Keywords

FimasartanLinagliptin

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

Sequence A

EXPERIMENTAL

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)Drug: Treatment B (Fimasartan/Linagliptin)

Sequence B

EXPERIMENTAL

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)Drug: Treatment B (Fimasartan/Linagliptin)

Sequency C

EXPERIMENTAL

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)Drug: Treatment B (Fimasartan/Linagliptin)

Interventions

Treatment A (Fimasartan, Linagliptin)DRUG

Co-administration of Fimasartan and Linagliptin

Sequence ASequence BSequency C
Treatment B (Fimasartan/Linagliptin)DRUG

Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg

Sequence ASequence BSequency C

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Dahak-ro, 03080, South Korea

Location

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Interventions

fimasartanLinagliptin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsQuinazolines

Study Officials

  • Kyung-Sang Yu, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2018

First Posted

August 1, 2018

Study Start

July 18, 2018

Primary Completion

March 4, 2019

Study Completion

June 30, 2019

Last Updated

February 5, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)