The Pharmacokinetic Interaction Between Amlodipine and Losartan
NCT ID: NCT03912285
Last Updated: 2019-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2008-01-10
2009-06-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Amlodipine10mg
Amlodipine 10mg will be administered orally twice a day for 9 days
Losartan potassium 100mg
Losartan 100mg will be administered orally once a day for 9 days
Amlodipine plus Losartan
Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"
Interventions
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Amlodipine10mg
Amlodipine 10mg will be administered orally twice a day for 9 days
Losartan potassium 100mg
Losartan 100mg will be administered orally once a day for 9 days
Amlodipine plus Losartan
Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
45 Years
MALE
Yes
Sponsors
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Hanmi Pharmaceutical co., ltd.
OTHER
Korea University Anam Hospital
OTHER
Responsible Party
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Ji-Young Park
Professor
Locations
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Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Seoul, , South Korea
Countries
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Other Identifiers
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HM-ALOS-101
Identifier Type: -
Identifier Source: org_study_id
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