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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