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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ESR 1150 CL, Capsule, oral; Drug: ESR 1150 CL, solution, intravenous

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESR 1150 CL capsule	Drug: ESR 1150 CL, Capsule, oral
Experimental: ESR 1150 CL ampoule	Drug: ESR 1150 CL, solution, intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
number of adverse events	up to day 22

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: November 1, 1998
• Primary Completion (Actual): December 1, 1998

Study Registration Dates

• First Submitted: July 4, 2014
• First Submitted That Met QC Criteria: July 4, 2014
• First Posted (Estimate): July 8, 2014

Study Record Updates

• Last Update Posted (Estimate): July 8, 2014
• Last Update Submitted That Met QC Criteria: July 4, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 1172.1