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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ESR 1150 CL, solution, intravenous; Drug: ESR 1150 CL, Capsule, oral

Study type: Interventional

Funder types: Industry

Identifiers

NCT02183259

1172.1

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

ESR 1150 CL capsule

Experimental group

Treatment:

Drug: ESR 1150 CL, Capsule, oral

ESR 1150 CL ampoule

Experimental group

Treatment:

Drug: ESR 1150 CL, solution, intravenous