NCT02243319

Brief Summary

The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2014

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 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 17, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

3 months

First QC Date

August 24, 2014

Last Update Submit

October 19, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax,ss of HGP1201, HGP0904

    1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h

  • AUCτ,ss of HGP1201, HGP0904

    1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h

Study Arms (6)

Group 1

EXPERIMENTAL

A → B → C A: HGP1201 for 9 days B: HGP0904 for 9 days C: HGP1201+ HGP0904 for 9 days

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Group 2

EXPERIMENTAL

C → A → B

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Group 3

EXPERIMENTAL

B → C → A

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Group 4

EXPERIMENTAL

C → B → A

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Group 5

EXPERIMENTAL

B → A → C

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Group 6

EXPERIMENTAL

A → C → B

Drug: HGP1201Drug: HGP0904Drug: HGP0904 and HGP1201 co-administraion

Interventions

HGP1201DRUG
Group 1Group 2Group 3Group 4Group 5Group 6
HGP0904DRUG
Group 1Group 2Group 3Group 4Group 5Group 6
HGP0904 and HGP1201 co-administraionDRUG
Group 1Group 2Group 3Group 4Group 5Group 6

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteer, age 19\~45 years
  • The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.

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
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

  • Hyeong-Seok Lim, MD PhD

    Asan Medical Center

    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 24, 2014

First Posted

September 17, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

October 20, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)