Healthy
Conditions
Brief summary
The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
Detailed description
Randomized, open-label, multiple dose , 3-treatment, 6-sequence, 3-period, crossover study, The purpose of this study is to investigate the pharmacokinetic drug interactions between HGP1201 and HGP0904
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
* Healthy male volunteer, age 19\ 45 years * The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 28 kg/m2 * Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial.
Exclusion criteria
* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study * History of relevant drug allergies or clinically significant hypersensitivity reaction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax,ss of HGP1201, HGP0904 | 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h |
| AUCτ,ss of HGP1201, HGP0904 | 1D 0h(predose), 8D 0h, 9D 0h, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 10D 0h, 11D 0h, 12D 0h |
Countries
South Korea
Outcome results
None listed