NCT04081844

Brief Summary

An Open-label, Multiple-dose, Fixed-sequence, 3-Period Study to Evaluate the Pharmacokinetic and Pharmacodynamic Interactions between HGP0904, HGP0608 and HCP1306 in Healthy Male Subjects

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1 healthy

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

May 3, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
Last Updated

September 9, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

September 2, 2019

Last Update Submit

September 5, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (12)

  • Cmax,ss of Amlodipine

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of Amlodipine

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax,ss of Losartan

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of Losartan

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax,ss of EXP3174

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of EXP3174

    Pharmacokinetic evaluation

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax,ss of Rosuvastatin

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: pre-dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of Rosuvastatin

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax,ss of Free Ezetimibe

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of Free Ezetimibe

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax,ss of Total Ezetimibe

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCtau of Total Ezetimibe

    Pharmacokinetic evaluation

    D1: pre-dose(0 hour), D5: dose(0 hour), D6: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Secondary Outcomes (18)

  • Cmin,ss of Amlodipine

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • T max,ss of Amlodipine

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • T1/2 of Amlodipine

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmin,ss of Losartan

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • T max,ss of Losartan

    D18: pre-dose(0 hour), D26: pre-dose(0 hour), D27: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hour, D29: pre-dose(0 hour), D33: pre-dose(0 hour), D34: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • +13 more secondary outcomes

Study Arms (1)

Fixed-Sequence

EXPERIMENTAL

Period 1: Fasted state+HCP1306, Period 2: Fasted state+HGP0904+HGP0608, Period 3: Fasted state+HCP1306+HGP0904+HGP0608

Drug: HCP1306Drug: HGP0904Drug: HGP0608

Interventions

HCP1306DRUG

Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet)

Fixed-Sequence
HGP0904DRUG

Amlodipine 5mg(Norvasc)

Fixed-Sequence
HGP0608DRUG

Losartan 100mg(Cozaar)

Fixed-Sequence

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 19\~45 years in healthy volunteers
  • BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
  • Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

You may not qualify if:

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Hospital (Anam)

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

September 2, 2019

First Posted

September 9, 2019

Study Start

May 3, 2018

Primary Completion

June 28, 2018

Study Completion

June 28, 2018

Last Updated

September 9, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)