NCT02183259

Brief Summary

To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1998

Completed
15.6 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

July 8, 2014

Status Verified

July 1, 2014

Enrollment Period

1 month

First QC Date

July 4, 2014

Last Update Submit

July 4, 2014

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • Area under the plasma drug concentration-time curve from time zero to infinity

    up to 16 hours after drug administration

  • maximum drug plasma concentration (Cmax)

    up to 16 hours after drug administration

  • time to achieve maximum drug plasma concentration (tmax)

    up to 16 hours after drug administration

  • elimination half-life (t1/2)

    up to 16 hours after drug administration

  • mean residence time (MRT)

    up to 16 hours after drug administration

  • total clearance (CL)

    up to 16 hours after drug administration

Secondary Outcomes (1)

  • number of adverse events

    up to day 22

Study Arms (2)

ESR 1150 CL capsule

EXPERIMENTAL
Drug: ESR 1150 CL, Capsule, oral

ESR 1150 CL ampoule

EXPERIMENTAL
Drug: ESR 1150 CL, solution, intravenous

Interventions

ESR 1150 CL, Capsule, oralDRUG
ESR 1150 CL capsule
ESR 1150 CL, solution, intravenousDRUG
ESR 1150 CL ampoule

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects
  • age: \>= 20 and \<= 35 years
  • weight: \>= 50 to \<= 80 kg and within +/- 20 % of standard weight
  • blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
  • pulse rate: 45 to 80 beat/min
  • volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up

You may not qualify if:

  • history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
  • history of drug allergy
  • history of drug dependency, alcohol dependency, etc.
  • use of other trial drug within 6 months before study drug administration
  • use of any drugs within 7 days before study drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CapsulesSolutions

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

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 4, 2014

First Posted

July 8, 2014

Study Start

November 1, 1998

Primary Completion

December 1, 1998

Last Updated

July 8, 2014

Record last verified: 2014-07