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Pharmacodynamics, Safety and Pharmacokinetics After Oral Administration of BIBR 1048 MS in Healthy Volunteers

NCT02170116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-06-23

No results posted yet for this study

Summary

The objective of this study was to assess safety, pharmacokinetics and the effect of BIBR 953 ZW on coagulation parameters of BIBR 953 ZW after oral single doses of the prodrug, BIBR 1048 MS, in healthy male subjects. This was the first administration of this substance to humans.

Conditions

  • Healthy

Interventions

DRUG

BIBR 1048 MS dose 1

DRUG

BIBR 1048 MS dose 2

DRUG

BIBR 1048 MS dose 3

DRUG

BIBR 1048 MS dose 4

DRUG

BIBR 1048 MS dose 5

DRUG

Placebo to BIBR 1048 MS

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-11-30
Primary Completion
1998-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02170116 on ClinicalTrials.gov