NCT02504606

Brief Summary

This clinical trial was evaluated to compare the safety and pharmacokinetics of Besylsartan with Amosartan, which was available commercially after single oral dose in healthy male subjects.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1 hypertension

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

September 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
Last Updated

July 22, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

July 17, 2015

Last Update Submit

July 20, 2015

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in blood concentration of Amlodipine

    Detect the change of blood concentration of Amlodipine by LC-MS/MS

    144 hour

  • Change from baseline in blood concentration of Losartan

    Detect the change of blood concentration of Losartan by LC-MS/MS

    10 hour

Study Arms (2)

Besylsartan

EXPERIMENTAL

amlodipine besylate 6.944mg+losartan K 100mg

Drug: Besylsartan

Amosartan

ACTIVE COMPARATOR

amlodipine besylate 7.841mg+losartan K 100mg

Drug: Amosartan

Interventions

BesylsartanDRUG

Amlodipin besylate 6.944mg+Losartan K 100mg

Besylsartan
AmosartanDRUG

Amlodipin besylate 7.841mg+Losartan K 100mg

Amosartan

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body Mass Index (BMI) between 18 and 30
  • Healthy as determined by a responsible physician

You may not qualify if:

  • History of clinically significant disease
  • Any chronic disease
  • Creatine clearance less than 50ml/min
  • Hypotension (100mmHg/60mmHg)
  • Treatment of barbital type drug within 1 month
  • Administration of herbal medicine within 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 22, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

July 22, 2015

Record last verified: 2015-07