The Pharmacokinetic Interaction Between Amlodipine and Losartan

Healthy Clinical Trial

Official title:

Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03912285
• Other study ID #: HM-ALOS-101
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2008
• Est. completion date: June 9, 2009

Study information

• Verified date: April 2019
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 9, 2009
• Est. primary completion date: March 17, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 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"

Locations

Country	Name	City	State
Korea, Republic of	Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Anam Hospital	Hanmi Pharmaceutical co., ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Cmax,ss(Maximum plasma concentration of the drug at steady state)		0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary	Cmin,ss(Minimum concentration of the drug in plasma at steady state)		0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary	Tmax,ss(Time to maximum plasma concentration at steady state)		0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary	1/2(Terminal elimination half-life)		0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary	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
Secondary	Vd,ss/F(Apparent volume of distribution at steady state)		0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary	PTF(Peak-to-trough fluctuation)		0 (predose) ~ 24 hours at day 9, day 31, and day 46