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Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.

NCT02232802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-10-20

Study results available
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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.

Conditions

  • Enoxaparin Sodium is Administered to Healthy Volunteers

Interventions

DRUG

Enoxaparin Sodium

comparison of bioavailability of generic Enoxaparin Sodium and Clexane

DRUG

Enoxaparin Sodium

comparison of bioavailability of generic Enoxaparin Sodium and Clexane

Sponsors & Collaborators

  • Chemi S.p.A.

    lead INDUSTRY

Principal Investigators

  • Paolo Bettica, MD · Italfarmaco S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-08-04
Primary Completion
2014-12-05
Completion
2014-12-05

Countries

  • United Kingdom

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 NCT02232802 on ClinicalTrials.gov