The Pharmacokinetic Interaction Between Amlodipine and Losartan

Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Amlodipine10mg; Drug: Losartan potassium 100mg; Drug: Amlodipine plus Losartan

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 136-705
    • Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Collaborators: Hanmi Pharmaceutical co., ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2008
• Primary Completion (Actual): March 17, 2009
• Study Completion (Actual): June 9, 2009

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Amlodipine; Losartan
• Other Study ID Numbers: HM-ALOS-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No