NCT04762407

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HCP1903 in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2020

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

November 20, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2021

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2021

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

February 18, 2021

Last Update Submit

July 12, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Cmax of Rosuvastatin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUClast of Rosuvastatin

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Cmax of Free Ezetimibe

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUClast of Free Ezetimibe

    pharmacokinetic evaluation

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

Secondary Outcomes (17)

  • Cmax of Total Ezetimibe

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUClast of Total Ezetimibe

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • AUCinf of Rosuvastatin

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • Tmax of Rosuvastatin

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • t1/2 of Rosuvastatin

    pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72 hour

  • +12 more secondary outcomes

Study Arms (2)

Sequence 1

EXPERIMENTAL

Period 1 : Fasted state + HGP1910 + HGP1909, Period 2 : Fasted state + HCP1903

Drug: HGP1910Drug: HGP1909Drug: HCP1903

Sequence 2

EXPERIMENTAL

Period 1 :Fasted state + HCP1903, Period 2 : Fasted state + HGP1910 + HGP1909

Drug: HGP1910Drug: HGP1909Drug: HCP1903

Interventions

HGP1910DRUG

Take it once per period.

Sequence 1Sequence 2
HGP1909DRUG

Take it once per period.

Sequence 1Sequence 2
HCP1903DRUG

Take it once per period.

Sequence 1Sequence 2

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 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 Anam Hospital

Seoul, South Korea

Location

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

February 18, 2021

First Posted

February 21, 2021

Study Start

November 20, 2020

Primary Completion

February 24, 2021

Study Completion

February 24, 2021

Last Updated

July 14, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)