Clinical trial NCT02166398: A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers
Official title: Phase 1 Study of Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Amlodipine basylate, Losartan potassium
Lead sponsor: Korea United Pharm. Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-18
Enrollment: 46
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Detailed description: A randomized, open-label, single dose, two-way crossover clinical trial to compare the safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single oral administration in healthy male volunteers

Eligibility criteria: Inclusion Criteria:

* Patients over 20 under 45 years of age
* BMI state over 19 under 27

Exclusion Criteria:

* mean sit SBP≥100mmHg or mean sit DBP≥150mmHg at screening
* mean sit SBP≥65mmHg or mean sit DBP≥95mmHg at screening
* Patients showed clinically significant hematological finding, patients with renal diseases (serum creatinine), patients with hepatic disease (ALT or AST)
* History of alcohol or drug abuse
* Positive to pregnancy test, nursing mother, has an intention on pregnancy
* Considered by investigator as not appropriate to participate in the clinical study with othe reason

Primary outcomes:
measure: AUClast of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: AUCinf of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: Cmax of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: AUClast of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
measure: AUCinf of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
measure: Cmax of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
Secondary outcomes:
measure: Tmax of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: t1/2 of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: CL/F of Amlodipine
timeFrame: 1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose
measure: Tmax of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
measure: t1/2 of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
measure: CL/F of Losartan
timeFrame: 1d,15d 0h pre-dose, 0.25, 0.5, 0.75, 1, 1.25 1.5, 2, 3, 4, 6, 8, 10, 12h post-dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
Study officials:
References: