NCT02554136

Brief Summary

The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2015

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

July 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 17, 2015

Last Update Submit

September 17, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • baseline-corrected Cmax of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • baseline-corrected AUCt of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • Cmax of HGP0816

    0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

  • AUCt of HGP0816

    0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

Secondary Outcomes (9)

  • Cmax of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • AUCt of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • Tmax of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • t1/2β of HGP0918

    -20, -16, -12, 0(predose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72hr (Total 16)

  • AUC∞ of HGP0816

    0(predose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72hr (Total 13)

  • +4 more secondary outcomes

Study Arms (6)

Sequence 1

EXPERIMENTAL

HGP0918 -\> HGP0816 -\> HGP0918 + HGP0816

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Sequence 2

EXPERIMENTAL

HGP0816 -\> HGP0918 + HGP0816 -\> HGP0918

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Sequence 3

EXPERIMENTAL

HGP0918 + HGP0816 -\> HGP0918 -\> HGP0816

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Sequence 4

EXPERIMENTAL

HGP0918 -\> HGP0918 + HGP0816 -\> HGP0816

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Sequence 5

EXPERIMENTAL

HGP0816 -\> HGP0918 -\> HGP0918 + HGP0816

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Sequence 6

EXPERIMENTAL

HGP0918 + HGP0816 -\> HGP0816 -\> HGP0918

Drug: HGP0918Drug: HGP0816Drug: HGP0918 + HGP0816

Interventions

HGP0918DRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
HGP0816DRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6
HGP0918 + HGP0816DRUG
Sequence 1Sequence 2Sequence 3Sequence 4Sequence 5Sequence 6

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • Healthy male volunteers, aged 19 to 55 years.
  • The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

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
  • Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
  • Somenone has a declined kidney function and his eGFR \< 60mL/min/1.73m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje Busan Paik hospital

Busan, 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

September 17, 2015

First Posted

September 18, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

KR(1)