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A Single-Dose Study to Examine the Within Subject Variability of Clexane® in Healthy Adult Subjects Under Fasting Conditions

Information source: Chemi S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Clexane is Administered to Healthy Volunteers

Intervention: Enoxaparin sodium (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Chemi S.p.A.

Official(s) and/or principal investigator(s):
Paolo Bettica, MD, Study Director, Affiliation: Italfarmaco S.p.A.


This is a pilot, open-label study aimed at a preliminary evaluation of enoxaparin bioavailability following two administrations of Clexane s. c. at a dose of 80mg, in two different periods.

Clinical Details

Official title: A Single-Dose Study to Examine the Within Subject Variability of Clexane (80 mg) s.c. in Healthy Adult Subjects Under Fasting Conditions

Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: Within subject variability of Enoxaparin sodium given subcutaneously in Healthy volunteers

Secondary outcome: number of participants with Adverse Events


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


Inclusion Criteria:

- Healthy male or female volunteer between 18 and 55 years of age.

- Female subject of child bearing potential with a negative pregnancy test at the

Screening Visit and willing to use 2 effective methods of contraception from Day 1 until 3 months afterwards.

- Subject with no clinically significant abnormal serum biochemistry, haematology,

coagulation factors and urine examination values within 14 days of the first dose. Exclusion Criteria:

- Female subject with weight < 45 kg or male subject with weight < 57 kg.

- Subject with clinically relevant abnormal physical findings which could interfere

with the objective of the study.

- Subject with clinically relevant abnormal laboratory values indicative of physical

illness; Hemoglobin <13 g/dL; Absolute platelet count below 100 x 109/L.

- Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low

molecular weight heparins, and/or pork products.

- Subject with a relevant history or presence of significant cardiovascular, pulmonary,

hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. In addition, history or presence of: alcoholism or drug abuse within the past year; clotting disorders; gastric or duodenal ulcers; hypertension; retinopathy; deep venous thrombosis; pulmonary embolism; GI bleeding.

- Subject with any clinically significant illness within 4 weeks prior to dosing.

- Subject with recent use of NSAID and/or aspirin (within 4 weeks of first dose) or the

use of any pharmacological agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days of the first dose. No subject may take any antibiotic agent known to interfere with intestinal microflora within 30 days of the first dose. Subjects with any medical condition requiring regular treatment with prescription drugs.

Locations and Contacts

Simbec Research Ltd, Merthyr Tydfil CF48 4DR, United Kingdom
Additional Information

Starting date: March 2014
Last updated: April 3, 2014

Page last updated: August 23, 2015

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