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The Pharmacokinetic Interaction Between Amlodipine and Losartan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912285
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Hanmi Pharmaceutical co., ltd.
Information provided by (Responsible Party):
Ji-Young Park, Korea University Anam Hospital

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Amlodipine10mg Drug: Losartan potassium 100mg Drug: Amlodipine plus Losartan Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Intervention Model Description: an open-label, three-period, fixed-sequence clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans
Actual Study Start Date : January 10, 2008
Actual Primary Completion Date : March 17, 2009
Actual Study Completion Date : June 9, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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.

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"




Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. 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 ]
  2. Tmax,ss(Time to maximum plasma concentration at steady state) [ Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46 ]
  3. 1/2(Terminal elimination half-life) [ Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46 ]
  4. 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 ]
  5. Vd,ss/F(Apparent volume of distribution at steady state) [ Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46 ]
  6. PTF(Peak-to-trough fluctuation) [ Time Frame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03912285


Locations
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Korea, Republic of
Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, Korea, Republic of, 136-705
Sponsors and Collaborators
Korea University Anam Hospital
Hanmi Pharmaceutical co., ltd.

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Responsible Party: Ji-Young Park, Professor, Korea University Anam Hospital
ClinicalTrials.gov Identifier: NCT03912285    
Other Study ID Numbers: HM-ALOS-101
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Losartan
Amlodipine
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists