NCT03629067

Brief Summary

The purpose of this study is to evaluate the Pharmacokinetics and safety/tolerability between Fimasartan/Amlodipine/Hydrochlorothiazide and co administration of Fimasartan/Amlodipine and Hydrochlorothiazide in Healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

August 9, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

August 9, 2018

Last Update Submit

January 8, 2019

Conditions

Pharmacokinetics

Keywords

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Cmax

    Maximum Concentration of Fimasartan, Amlodipine, Hydrochlorothiazide in plasma

    0~144hours after Medication

Secondary Outcomes (1)

  • AUCinf

    0~144hours after medication

Study Arms (3)

Sequence A

EXPERIMENTAL

Period 1(Treatment R) - Period 2(Treatment R) - Period 3(Treatment T) There will be a 14 washout of days between the each period.

Drug: Treatment TDrug: Treatment R

Sequence B

EXPERIMENTAL

Period 1(Treatment R) - Period 2(Treatment T) - Period 3(Treatment R) There will be a 14 washout of days between the each period.

Drug: Treatment TDrug: Treatment R

Sequence C

EXPERIMENTAL

Period 1(Treatment T) - Period 2(Treatment R) - Period 3(Treatment R) There will be a 14 washout of days between the each period.

Drug: Treatment TDrug: Treatment R

Interventions

Treatment TDRUG

Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide

Also known as: FAH
Sequence ASequence BSequence C
Treatment RDRUG

Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide

Also known as: FA/H
Sequence ASequence BSequence C

Eligibility Criteria

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

You may qualify if:

  • A healthy adults aged 19-50 years

You may not qualify if:

  • History or presence of clinically significant medical or psychiatric condition or disease
  • Hypersensitivity to ingredient of IP and other medication, food
  • Participation in any other study within 3months
  • History of whole blood donation within 2months and Apheresis 1month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 100-744, South Korea

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kyung-sang Yu

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 9, 2018

First Posted

August 14, 2018

Study Start

September 13, 2018

Primary Completion

November 29, 2018

Study Completion

December 27, 2018

Last Updated

January 10, 2019

Record last verified: 2019-01

Locations

KR(1)