Healthy
Conditions
Brief summary
The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 in healthy male volunteers
Detailed description
A randomized, open-label, single dose, crossover clinical trial to investigate and compare the pharmacokinetics between HIP1403 and HGP0919 in healthy male volunteers.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
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 27 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oseltamivir Cmax, AUClast , AUCinf | 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16) |
Secondary
| Measure | Time frame |
|---|---|
| Oseltamivir Tmax | 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16) |
| Oseltamivir t1/2 | 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16) |
| Oseltamivir CL/F | 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16) |
| Oseltamivir Vd/F | 0h(predose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48hours (Total 16) |
Countries
South Korea
Outcome results
None listed