A Single-Dose Trial to Examine the Within Subject Variability of Clexane® in Healthy Adults Under Fasting Conditions
Condition: Clexane is Administered to Healthy Volunteers
Intervention: Enoxaparin sodium
Intervention description: comparison of 2 different administration of drug
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: enoxaparin sodium

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.
    

Eligibility 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.

          -  Subject with recent severe trauma, surgery (eye surgery), and/or lumbar puncture;

          -  Female subject who was pregnant or lactating.

          -  Subject who was a vegetarian.

          -  Subject who, through completion of the study, would have donated in excess of 500 mL
             of blood and/or plasma within the previous 3 months.

          -  Subject who regularly consumed excessive amounts of alcohol.

          -  Subject who consumed excessive amount of caffeine (> 5 cups of coffee or equivalent
             per day).

          -  Subject who was a smoker (cigarettes and tobacco-related products), or ex-smoker who
             had smoked in the 3 months preceding the study. Subjects were tested for urinary
             cotinine at screening.

          -  Subjects who could not tolerate venepuncture.

          -  Inability to communicate well with the Investigator (i.e., language problem, poor
             mental development or impaired cerebral function).

          -  Participation in a New Chemical Entity clinical study within the previous 4 months or
             a marketed drug clinical study within the previous 3 months.