CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 47 enrolled
Drug / intervention
Enoxaparin Sodium +1 moredrug
Likely dose
Not stated in 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/NCT02232802
NCT02232802Phase 1Completed

Comparative, Randomized, Single-dose, 2-way Cross Over Bioavailability Study of Enoxaparin Sodium Chemi (80 mg/0.8mL) and Clexane® (80 mg/0.8mL) s.c. in Healthy Adult Subjects Under Fasting Conditions.

Chemi S.p.A.·interventional·Posted Sep 5, 2014·Updated Oct 20, 2020

In Brief

A Phase 1 clinical trial evaluating Enoxaparin Sodium for Enoxaparin Sodium is Administered to Healthy Volunteers. Completed, enrolled 47 participants across 1 site.

Detailed Summary

* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers. * The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 5, 2014
Enrollment StartAug 4, 2014
Primary CompletionDec 5, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.8 years ago

Interventions

Enoxaparin Sodiumdrug

comparison of bioavailability of generic Enoxaparin Sodium and Clexane

Enoxaparin Sodiumdrug

comparison of bioavailability of generic Enoxaparin Sodium and Clexane