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)

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.

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