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

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ClinicalTrials.gov Identifier: NCT02183259
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: ESR 1150 CL, Capsule, oral Drug: ESR 1150 CL, solution, intravenous Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 1998
Actual Primary Completion Date : December 1998

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

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



Primary Outcome Measures :
  1. Area under the plasma drug concentration-time curve from time zero to infinity [ Time Frame: up to 16 hours after drug administration ]
  2. maximum drug plasma concentration (Cmax) [ Time Frame: up to 16 hours after drug administration ]
  3. time to achieve maximum drug plasma concentration (tmax) [ Time Frame: up to 16 hours after drug administration ]
  4. elimination half-life (t1/2) [ Time Frame: up to 16 hours after drug administration ]
  5. mean residence time (MRT) [ Time Frame: up to 16 hours after drug administration ]
  6. total clearance (CL) [ Time Frame: up to 16 hours after drug administration ]

Secondary Outcome Measures :
  1. number of adverse events [ Time Frame: up to day 22 ]


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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02183259     History of Changes
Other Study ID Numbers: 1172.1
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014