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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02183259

Enrollment

Registered

2014-07-08

Start date

1998-11-30

Completion date

Unknown

Last updated

2014-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGESR 1150 CL, Capsule, oral

DRUGESR 1150 CL, solution, intravenous

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
time to achieve maximum drug plasma concentration (tmax)	up to 16 hours after drug administration
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
total clearance (CL)	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

Secondary

Measure	Time frame
number of adverse events	up to day 22

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026