The Pharmacokinetic Interaction Between Amlodipine and Losartan

Overview

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

Full Title of Study: “Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 17, 2009

Interventions

  • Drug: Amlodipine10mg
    • Amlodipine 10mg will be administered orally twice a day for 9 days
  • Drug: Losartan potassium 100mg
    • Losartan 100mg will be administered orally once a day for 9 days
  • Drug: Amlodipine plus Losartan
    • Amlodipine plus Losartan same way as “arm: amlodipine” and “arm: losartan”

Arms, Groups and Cohorts

  • Experimental: Amlodipine, losartan, and 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.

Clinical Trial Outcome Measures

Primary Measures

  • AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
  • Cmax,ss(Maximum plasma concentration of the drug at steady state)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

Secondary Measures

  • Cmin,ss(Minimum concentration of the drug in plasma at steady state)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
  • Tmax,ss(Time to maximum plasma concentration at steady state)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
  • 1/2(Terminal elimination half-life)
    • Time Frame: 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)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
  • Vd,ss/F(Apparent volume of distribution at steady state)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
  • PTF(Peak-to-trough fluctuation)
    • Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 20 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Korea University Anam Hospital
  • Collaborator
    • Hanmi Pharmaceutical co., ltd.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji-Young Park, Professor – Korea University Anam Hospital

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