NCT02166398

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jun 2014

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

June 12, 2015

Status Verified

June 1, 2015

Enrollment Period

4 months

First QC Date

June 16, 2014

Last Update Submit

June 10, 2015

Conditions

Healthy

Keywords

Amlodipine basylate, Losartan potassium

Outcome Measures

Primary Outcomes (6)

  • AUClast of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • AUCinf of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • Cmax of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • AUClast of Losartan

    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

  • AUCinf of Losartan

    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

  • Cmax of Losartan

    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 (6)

  • Tmax of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • t1/2 of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • CL/F of Amlodipine

    1d,15d 0h pre-dose, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144h post-dose

  • Tmax of Losartan

    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

  • t1/2 of Losartan

    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

  • +1 more secondary outcomes

Study Arms (2)

Amosartan 5/50 tab

ACTIVE COMPARATOR

Amosartan 5/50 tab given by oral administration

Drug: Amosartan 5/50

UI15AML055MT tab

EXPERIMENTAL

UI15AML055MT tab given by oral administration

Drug: UI15AML055MT

Interventions

UI15AML055MTDRUG

tab, PO

UI15AML055MT tab
Amosartan 5/50DRUG

tab, PO

Amosartan 5/50 tab

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 110-744, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

June 12, 2015

Record last verified: 2015-06

Locations

KR(1)