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Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

NCT01063101 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-05

No results posted yet for this study

Summary

The purpose of the study is to investigate whether orally administered BAX 513 (different doses administered for 5 days) affects hemostatic parameters in healthy volunteers.

Conditions

  • Healthy Volunteers

Interventions

OTHER

Fucoidan (extract of Laminaria japonica)

Capsule (300 mg/capsule) - oral administration - 5 different dose levels - BID

OTHER

Placebo

Cellulose filled capsule - oral administration - 5 different dose levels - BID

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-29
Primary Completion
2010-07-22
Completion
2010-08-01

Countries

  • Austria

Study Locations

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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 NCT01063101 on ClinicalTrials.gov