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

NCT ID: NCT02183259

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-11-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESR 1150 CL capsule

Group Type EXPERIMENTAL

ESR 1150 CL, Capsule, oral

Intervention Type DRUG

ESR 1150 CL ampoule

Group Type EXPERIMENTAL

ESR 1150 CL, solution, intravenous

Intervention Type DRUG

Interventions

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ESR 1150 CL, Capsule, oral

Intervention Type DRUG

ESR 1150 CL, solution, intravenous

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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1172.1

Identifier Type: -

Identifier Source: org_study_id

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