Clinical trial NCT03912285: The Pharmacokinetic Interaction Between Amlodipine and Losartan
Official title: Pharmacokinetic and Hemodynamic Interactions Between Amlodipine and Losartan in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Hanmi Pharmaceutical co., ltd.
First posted: 2019-04-11
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: an open-label, three-period, fixed-sequence clinical trial
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: AUCtau(area under the plasma concentration-time curve for a dosing interval at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: Cmax,ss(Maximum plasma concentration of the drug at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Secondary outcomes:
measure: Cmin,ss(Minimum concentration of the drug in plasma at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: Tmax,ss(Time to maximum plasma concentration at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: 1/2(Terminal elimination half-life)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: CLss/F(Apparent total body clearance of the drug from plasma at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: Vd,ss/F(Apparent volume of distribution at steady state)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
measure: PTF(Peak-to-trough fluctuation)
timeFrame: 0 (predose) ~ 24 hours at day 9, day 31, and day 46
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dept. of Clinical Pharmacology & Toxicology, Anam Hospital, Korea University College of Medicine
Study officials:
References: