CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
Heparin, Low-Molecular-Weightdrug
Likely dose
Heparin, Low-Molecular-Weight 3mg/Kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01692171
NCT01692171Phase 1Completed
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Pharmacodynamics Study of Enoxalow, Produced by Blau Farmacêutica S/A, Compared to Clexane, Produced by Sanofi-Aventis Farmacêutica Ltda, in Healthy Subjects After Intravenous Administration.

Azidus Brasil·interventional·Posted Sep 25, 2012·Updated Oct 31, 2022

In Brief

A Phase 1 clinical trial evaluating Heparin, Low-Molecular-Weight for Healthy. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The hypothesis of this trial is that the test drug (Enoxalow® - T) pharmacodynamics parameters are similar to the comparator drug (Clexane® - C) in healthy subjects following administration of single intravenous dose. The objective of this randomized, crossover, clinical trial is to evaluate the pharmacodynamic profile of the test drug Enoxalow® - T produced by Blau Farmacêutica, compared to the comparator drug Clexane®, produced by Sanofi-Aventis, by determining pharmacodynamic activities (including anti FXa and anti-FIIa), as surrogate markers for their circulating concentrations of the drug.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesBrazil
CollaboratorsBlau Farmaceutica S.A.

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartFeb 28, 2013
Primary CompletionOct 31, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.8 years ago

Interventions

Heparin, Low-Molecular-Weightdrug

single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.