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A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions

NCT02081950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2020-11-12

Study results available
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Summary

Primary: To examine the within subject variability of Clexane (80 mg) in healthy male and female volunteers administered subcutaneously (s.c.) as a single dose, in two periods, under fasting conditions.

Secondary: To monitor safety during the Treatment Periods.

Conditions

  • Clexane is Administered to Healthy Volunteers

Interventions

BIOLOGICAL

Enoxaparin sodium

comparison of 2 different administration of drug

Sponsors & Collaborators

  • Chemi S.p.A.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-03-31
Completion
2014-03-31

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 NCT02081950 on ClinicalTrials.gov