Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 suspensions in healthy male volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

HIP1403→HGP0919

Group Type EXPERIMENTAL

HIP1403

Intervention Type DRUG

Oseltamivir 6mg/mL

HGP0919

Intervention Type DRUG

Oseltamivir phosphate 6mg/mL

Sequence 2

HGP0919→HIP1403

Group Type EXPERIMENTAL

HIP1403

Intervention Type DRUG

Oseltamivir 6mg/mL

HGP0919

Intervention Type DRUG

Oseltamivir phosphate 6mg/mL

Interventions

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HIP1403

Oseltamivir 6mg/mL

Intervention Type DRUG

HGP0919

Oseltamivir phosphate 6mg/mL

Intervention Type DRUG

Other Intervention Names

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Oseltamivir 6mg/mL Tamiflu Oral Suspension 6mg/mL

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 29 kg/m2.
3. 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.

Exclusion Criteria

1. 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.
2. Positive serology for HBs antigen, HCV antibody, HIV antigen

Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes