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Etude (Study) Phase I Enox - UnFractionated Heparin (UFH)

NCT00622115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2011-03-15

No results posted yet for this study

Summary

Primary objective:

* to characterize the pharmacokinetic and the pharmacodynamic profile after intravenous bolus injection of unfractionated heparin (UFH) after repeated sc 100 IU anti-Xa/kg (corresponding to 1 mg/kg) twice a day during 2.5 days (every 12±2hrs) administrations of enoxaparin in Caucasian healthy subjects.

Secondary objective(s):

* to compare the pharmacokinetic and the pharmacodynamic profile between 3 different timing of administration of the UFH
* to assess the tolerability of the different anticoagulation protocols

Conditions

Interventions

DRUG

Enoxaparin

Sponsors & Collaborators

Principal Investigators

  • Kazuki Otani · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

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 NCT00622115 on ClinicalTrials.gov