The Pharmacokinetic Interaction Between Amlodipine and Losartan

NCT03912285 | Completed Phase 1 DMC

• 1 other identifier: HM-ALOS-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (1)

Amlodipine, losartan, and amlodipine plus losartan

EXPERIMENTAL

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; Drug: Losartan potassium 100mg; Drug: Amlodipine plus Losartan

Interventions

Amlodipine10mg DRUG

Amlodipine 10mg will be administered orally twice a day for 9 days

Amlodipine, losartan, and amlodipine plus losartan

Losartan potassium 100mg DRUG

Losartan 100mg will be administered orally once a day for 9 days

Amlodipine, losartan, and amlodipine plus losartan

Amlodipine plus Losartan DRUG

Amlodipine plus Losartan same way as "arm: amlodipine" and "arm: losartan"

Amlodipine, losartan, and amlodipine plus losartan

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Hanmi Pharmaceutical co., ltd.: collaborator

Study Sites (1)

Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine

Seoul, 136-705, South Korea

Location

MeSH Terms

Interventions

Losartan; Amlodipine

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dihydropyridines; Pyridines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: an open-label, three-period, fixed-sequence clinical trial

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: January 10, 2008
• Primary Completion: March 17, 2009
• Study Completion: June 9, 2009
• Last Updated: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)