The Pharmacokinetic Interaction Between Amlodipine and Losartan

Recruitment & Eligibility

Inclusion Criteria

Healthy volunteers aged between ≥ 20 and ≤ 45 years old
Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²
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
Subject who are informed of the investigational nature of this study, voluntarily agree to participate in this study

Exclusion Criteria

History or presence of a clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, hematological, gastrointestinal, endocrine, immune, dermatologic, neurologic or psychiatric disorder
With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration
Any medical history that may affect drug absorption, distribution, metabolism, and excretion
Genetic problems such as galactose intolerance, Lapp lactose dehydrogenase deficiency or glucose-galactose uptake disorder
Any clinically significant active chronic disease

Study & Design

Arm && Interventions

Group	Intervention	Description
Amlodipine, losartan, and amlodipine plus losartan	Amlodipine plus Losartan	Period 1: amlodipine 10mg will be administered orally once a day for 9 days. Period 2: losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period. Period 3: amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.
Amlodipine, losartan, and amlodipine plus losartan	Amlodipine10mg	Period 1: amlodipine 10mg will be administered orally once a day for 9 days. Period 2: losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period. Period 3: amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.
Amlodipine, losartan, and amlodipine plus losartan	Losartan potassium 100mg	Period 1: amlodipine 10mg will be administered orally once a day for 9 days. Period 2: losartan 100mg will be administered orally once a day for 9 days after 13 days of the washout period. Period 3: amlodipine 10mg once a day plus losartan 100mg once a day will be administered orally for 9 days after 6 days of the washout period.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PTF(Peak-to-trough fluctuation)	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
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
Cmin,ss(Minimum concentration of the drug in plasma at steady state)	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

Recruitment & Eligibility