Healthy
Conditions
Keywords
Pharmacokinetics
Brief summary
This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of amlodipine and valsartan (reference formulation) for single dose in healthy volunteers
Interventions
DRUGTest formulation
A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg
A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg
Sponsors
Severance Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease
Exclusion criteria
* History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; * Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests; * Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; * Use of any substance that could induce or inhibit drug metabolism enzymes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose | Cmax, Area Under Curve(0 to the last sampling time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Pharmacokinetics | 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72, 96, 144, 192 hours post-dose | Tmax, Area Under Curve(0 to infinity), T\_1/2 |
Countries
South Korea
Outcome results
None listed