The Pharmacokinetic Interaction Between Amlodipine and Losartan

Study Overview
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Brief Summary
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This clinical trial aims to assess the pharmacokinetic interaction between amlodipine and losartan in healthy male subjects.

Official Title
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Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans

Conditions
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Healthy

Intervention / Treatment
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* Drug: Amlodipine10mg
* Drug: Losartan potassium 100mg
* Drug: Amlodipine plus Losartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: an open-label, three-period, fixed-sequence clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amlodipine, losartan, and amlodipine plus losartan<br>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. | Drug: Amlodipine10mg<br>* Amlodipine 10mg will be administered orally twice a day for 9 days<br>Drug: Losartan potassium 100mg<br>* Losartan 100mg will be administered orally once a day for 9 days<br>Drug: Amlodipine plus Losartan<br>* Amlodipine plus Losartan same way as arm: amlodipine and arm: losartan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |