NCT02545829

Brief Summary

The purpose of this study is to investigate the bioequivalence after administration of HIP1302 and HGP1406 in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 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

August 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

August 13, 2015

Last Update Submit

October 12, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Tenofovir Cmax

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • Tenofovir AUClast

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

Secondary Outcomes (6)

  • Tenofovir Tmax

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • Tenofovir t1/2

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • Tenofovir CL/F

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • Tenofovir AUCinf

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • Tenofovir MRT

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72hour (Total 16)

  • +1 more secondary outcomes

Study Arms (2)

Sequence 1

EXPERIMENTAL

HGP1406 → HIP1302

Drug: HIP1302Drug: HGP1406

Sequence 2

EXPERIMENTAL

HIP1302 → HGP1406

Drug: HIP1302Drug: HGP1406

Interventions

HIP1302DRUG

Tenofovir 292mg

Sequence 1Sequence 2
HGP1406DRUG

Tenofovir 300mg

Sequence 1Sequence 2

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, age 19 to 50 years
  • The result of Body Mass Index(BMI) is not less than 18.0 kg/m2, no more than 27.0 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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

  • Kyung-Sang Yu, M.D.

    Seoul National University Hospital

    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 13, 2015

First Posted

September 10, 2015

Study Start

August 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)