NCT03089112

Brief Summary

A Randomized, Open-label, Crossover Study to Investigate the Pharmacokinetic drug interactions and the Safety between HGP1607 and HGP1501 in Healthy Male Volunteers

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2017

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

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

March 31, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2017

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2017

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

2 months

First QC Date

March 20, 2017

Last Update Submit

November 7, 2022

Conditions

Healthy Male Volunteers

Outcome Measures

Primary Outcomes (4)

  • AUClast of HGP1607

    16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  • Cmax of HGP1607

    16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  • baseline corrected AUClast of HGP1501

    0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  • baseline corrected Cmax of HGP1501

    0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

Secondary Outcomes (8)

  • AUCinf of HGP1607

    16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  • Tmax of HGP1607

    16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  • T1/2 of HGP1607

    16, -12, -8, 0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 24, 48, 72, 96,120h

  • AUClast of HGP1501

    0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  • Cmax of HGP1501

    0,1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 48, 72, 96,120h

  • +3 more secondary outcomes

Study Arms (6)

Seguence 1

EXPERIMENTAL

Period 1 : HGP1607 Period 2 : HGP1501 Period 3 : HGP1607+HGP1501

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Seguence 2

EXPERIMENTAL

Period 1 : HGP1607 Period 2 : HGP1607+HGP1501 Period 3 : HGP1501

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Seguence 3

EXPERIMENTAL

Period 1 : HGP1501 Period 2 : HGP1607 Period 3 : HGP1607+HGP1501

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Seguence 4

EXPERIMENTAL

Period 1 : HGP1501 Period 2 : HGP1607+HGP1501 Period 3 : HGP1607

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Seguence 5

EXPERIMENTAL

Period 1 : HGP1607+HGP1501 Period 2 : HGP1607 Period 3 : HGP1501

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Seguence 6

EXPERIMENTAL

Period 1 : HGP1607+HGP1501 Period 2 : HGP1501 Period 3 : HGP1607

Drug: HGP1607Drug: HGP1501Drug: HGP1607+HGP1501

Interventions

HGP1607DRUG

Take it once per period

Seguence 1Seguence 2Seguence 3Seguence 4Seguence 5Seguence 6
HGP1501DRUG

Take it once per period

Seguence 1Seguence 2Seguence 3Seguence 4Seguence 5Seguence 6
HGP1607+HGP1501DRUG

Take it once per period

Seguence 1Seguence 2Seguence 3Seguence 4Seguence 5Seguence 6

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age 19\~40 years
  • The result of BMI is not less than 19 kg/m2 , no more than 28 kg/m2
  • 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)

Seoul Asan 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

March 20, 2017

First Posted

March 24, 2017

Study Start

March 31, 2017

Primary Completion

May 28, 2017

Study Completion

June 16, 2017

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations

KR(1)