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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ESR 1150 CL, Capsule, oral; Drug: ESR 1150 CL, solution, intravenous

• Registration Number: NCT02183259
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-11
• Primary Completion: 1998-12
• Status Verified: 2014-07
• Study First Submitted: 2014-07-04
• Study First Submitted QC: 2014-07-04
• Last Update Submitted: 2014-07-04
• Study First Posted: 2014-07-08
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ESR 1150 CL capsule	ESR 1150 CL, Capsule, oral	-
ESR 1150 CL ampoule	ESR 1150 CL, solution, intravenous	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
number of adverse events	up to day 22