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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Pharmaceutical Solutions

Criteria

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