Overview

A Study Comparing the Local Tolerability of Two Subcutaneous Heparins in Healthy Volunteers.

Status:
Completed
Trial end date:
2016-07-15
Target enrollment:
0
Participant gender:
All
Summary
A Phase IV, Randomised, Double-blind, Single-centre clinical trial in healthy male and female participants aged 18 to 55, that was designed to assess and compare the pain intensity at an injection site as well as the duration of pain following a single dose subcutaneous administration of two low molecular weight heparins (LMWH) respectively.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Aspen Global Incorporated
Treatments:
Heparin
Criteria
Inclusion Criteria:

1. Male or Female participant.

2. Aged 18 years to 55 years.

3. Medically healthy participants.

4. Weight Females: ≥ 45 kg; Males ≥ 57 kg.

5. Body Mass Index (BMI) of 18,5 to 29,9 kg/m2.

6. Female participants of child-bearing potential must have a negative urine pregnancy
test at screening and be willing to use effective contraceptives throughout the trial
duration.

7. Participants must be able to understand and follow the instructions of the
Investigator, understand and give informed consent, and be willing, committed, and
able to return for all site visits and complete all study-related procedures.

Exclusion Criteria:

1. A known hypersensitivity to Clexane or Fraxiparine or any components thereof -
especially allergies to latex, pork products, sulfites and benzyl alcohols.

2. Female participants who are pregnant or lactating.

3. Any coagulopathy - Anaemia, thrombocytopenia, hemophilia, haemorrhagic diathesis
(Bleeding, Bruising, Clotting disorders).

4. Active gastric or duodenal ulcer or history of previous gastric duodenal bleeding or
gastrointestinal bleeding.

5. Participants on the following medications: Anti-coagulants, Non-Steroidal
Anti-inflammatory Drugs (NSAID)s, glycoprotein IIb/IIIa anticoagulants, thrombolytic
agents, platelet-inhibitors, acetylsalicylic acid, sulfinpyrazone, quinine -
containing remedies and/drinks, treprostinil, apixaban, drotecogin alfa, danshen, dong
quai, evening primrose oil, gingko, policosanol and willow bark as well as
hyperkalemia aggravators in the last 7 days.

6. A Cerebrovascular incident (hemorrhagic or ischemic).

7. Deep Vein Thrombosis and/ Pulmonary embolism.

8. Acute infective endocarditis or history of acute endocarditis.

9. Participants with Hypertension.

10. Diabetics.

11. Any injuries or surgery of the ears, eyes, brain or spinal cord within the last 18
months.

12. Renal insufficiency (Creatinine and Urea not within normal ranges).

13. Hepatic Insufficiency ( aspartate aminotransferase (AST) and alanine transaminase
(ALT) within normal ranges).

14. Participants with Heamorrhagic Retinopathy.

15. Participants with prosthetic heart valve/s.

16. Participants currently receiving any other treatments administered via subcutaneous or
intramuscular routes.

17. Participants with a history or current endocrine, pulmonary, cardiovascular,
gastrointestinal, neurological, immunological, renal, hepatic, dermatologic,
haematologic, psychiatric disease other than specified that might have/cause unwanted
effects/outcomes in this clinical trial.

18. Alcohol and/ or drug abuse in the past year.

19. In the opinion of the investigator, the participant is not reliable to participate in
the trial.

20. Participants that have taken part in a clinical trial involving Clexane and/
Fraxiparine.

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