Healthy
Conditions
Brief summary
This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.
Interventions
DRUGAmlodipine10mg
Amlodipine 10mg will be administered orally twice a day for 9 days
Losartan 100mg will be administered orally once a day for 9 days
Amlodipine plus Losartan same way as arm: amlodipine and arm: losartan
Sponsors
Hanmi Pharmaceutical co., ltd.
Korea University Anam Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
an open-label, three-period, fixed-sequence clinical trial
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old 2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m² 3. Subjects who agree to use a combination of effective contraceptive methods or medically acceptable contraceptive methods for up to 28 days after the date of administration of the clinical trial drug and agree not to provide sperm 4. Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study
Exclusion criteria
1. History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder 2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration 3. Any medical history that may affect drug absorption, distribution, metabolism, and excretion 4. Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder 5. Any clinically significant active chronic disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| Cmax,ss(Maximum plasma concentration of the drug at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
Secondary
| Measure | Time frame |
|---|---|
| Cmin,ss(Minimum concentration of the drug in plasma at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| Tmax,ss(Time to maximum plasma concentration at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| 1/2(Terminal elimination half-life) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| CLss/F(Apparent total body clearance of the drug from plasma at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| Vd,ss/F(Apparent volume of distribution at steady state) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
| PTF(Peak-to-trough fluctuation) | 0 (predose) ~ 24 hours at day 9, day 31, and day 46 |
Countries
South Korea
Outcome results
None listed