Skip to main content
OpenTrials
Completed

NCT Number: NCT02183259

Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ESR 1150 CL, Capsule, oral

Drug

ESR 1150 CL, solution, intravenous

Drug

Primary outcomes

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

    Time frame: up to 16 hours after drug administration

  2. maximum drug plasma concentration (Cmax)

    Time frame: up to 16 hours after drug administration

  3. time to achieve maximum drug plasma concentration (tmax)

    Time frame: up to 16 hours after drug administration

  4. elimination half-life (t1/2)

    Time frame: up to 16 hours after drug administration

  5. mean residence time (MRT)

    Time frame: up to 16 hours after drug administration

  6. total clearance (CL)

    Time frame: up to 16 hours after drug administration

Secondary outcomes

  1. number of adverse events

    Time frame: up to day 22

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)

Important dates

Study start
1998
Primary completion
1998
First posted
Jul 8, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.