Evaluating the Bioequivalence of HIP1403 and HGP0919 Suspensions

Study Overview
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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.

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.

Official Title
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An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics of HIP1403 in Healthy Male Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: HIP1403
* Drug: HGP0919


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>HIP1403→HGP0919 | Drug: HIP1403<br>* Oseltamivir 6mg/mL<br>* Other names: Oseltamivir 6mg/mL;Drug: HGP0919<br>* Oseltamivir phosphate 6mg/mL<br>* Other names: Tamiflu Oral Suspension 6mg/mL;|
| Experimental: Sequence 2<br>HGP0919→HIP1403 | Drug: HIP1403<br>* Oseltamivir 6mg/mL<br>* Other names: Oseltamivir 6mg/mL;Drug: HGP0919<br>* Oseltamivir phosphate 6mg/mL<br>* Other names: Tamiflu Oral Suspension 6mg/mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |