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

Boehringer Ingelheim18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

ESR 1150 CL, Capsule, oralDRUG

ESR 1150 CL, solution, intravenousDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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