Diabete Type 2, Hypertension
Conditions
Brief summary
This clinical trial is a two-arm, open-label, single-sequence, multiple oral dosings, cross-over design clinical trial to evaluate the safety and pharmacokinetic characteristics of HL1113-R1 and HL1113-R2 in healthy adult volunteers
Interventions
DRUGTest group 1
* Period 1: HL1113-R1, once daily, administered for 7 days * Period 2: HL1113-R1 + HL1113-R2 once daily, administered for 7 days
DRUGTest group 2
* Period 1: HL1113-R2, once daily, administered for 5 days * Period 2: HL1113-R2 + HL1113-R1 once daily, administered for 7 days
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy adult subjects aged ≥19 years at the time of screening * Subjects with no clinically significant congenital or chronic diseases based on screening, and no clinically significant findings on internal medicine examination (including, if necessary, electroencephalogram \[EEG\], electrocardiogram \[ECG\], chest examination, upper gastrointestinal endoscopy, or gastrointestinal radiography) * etc.
Exclusion criteria
* Subjects who have received medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to the screening visit * Subjects who have received any medications that may affect the outcome of the study within 10 days prior to the screening visit * etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCτ,ss | a steady state after 5~7 days of repeated administration |
Secondary
| Measure | Time frame |
|---|---|
| Tmax,ss | a steady state after 5~7 days of repeated administration |
Countries
South Korea
Outcome results
None listed