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