The Pharmacokinetic Interaction Between Amlodipine and Losartan

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03912285

Collaborator

Hanmi Pharmaceutical co., ltd. (Other)

Enrollment

Location

Arm

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

an open-label, three-period, fixed-sequence clinical trialan 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 :

Jan 10, 2008

Actual Primary Completion Date :

Mar 17, 2009

Actual Study Completion Date :

Jun 9, 2009

Arms and Interventions

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"

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"

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ji-Young Park, Professor, Korea University Anam Hospital

ClinicalTrials.gov Identifier:

NCT03912285

Other Study ID Numbers:

HM-ALOS-101

First Posted:

Apr 11, 2019

Last Update Posted:

Apr 12, 2019

Last Verified:

Apr 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Losartan

Amlodipine

Study Results

No Results Posted as of Apr 12, 2019