NCT02941731

Brief Summary

The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 suspensions in healthy male volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration 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

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
Last Updated

October 21, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

October 11, 2016

Last Update Submit

October 19, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Oseltamivir Cmax

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  • Oseltamivir AUClast , AUCinf

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

Secondary Outcomes (4)

  • Oseltamivir Tmax

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  • Oseltamivir t1/2

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  • Oseltamivir CL/F

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

  • Oseltamivir Vd/F

    0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48hours (Total 16)

Study Arms (2)

Sequence 1

EXPERIMENTAL

HIP1403→HGP0919

Drug: HIP1403Drug: HGP0919

Sequence 2

EXPERIMENTAL

HGP0919→HIP1403

Drug: HIP1403Drug: HGP0919

Interventions

HIP1403DRUG

Oseltamivir 6mg/mL

Also known as: Oseltamivir 6mg/mL
Sequence 1Sequence 2
HGP0919DRUG

Oseltamivir phosphate 6mg/mL

Also known as: Tamiflu Oral Suspension 6mg/mL
Sequence 1Sequence 2

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers, age 19 to 45 years.
  • The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 29 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.
  • Positive serology for HBs antigen, HCV antibody, HIV antigen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ji Young Park, MD, PhD

    Korea University Anam 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

October 11, 2016

First Posted

October 21, 2016

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 21, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)