healthy human volunteers
Conditions
Interventions
Experimental Drug,Active Comparator Drug
Enoxaparin-
SBS pre-
filled injection 60 mg/0.6 mL ,Clexane® pre-
filled injection 60 mg/0.6 mL
Sponsors
Siam Bioscience Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Willingness to provide written informed consent prior to participate in the study. 2. Healthy Thai subjects are between 18 to 55 years of age. 3. The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2 with body weight more than 45.0 kg (in women) or 57.0 kg (in men). 4. Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 10 mL of blood for monitoring subjects’ safety after the completion of the study. 5. Negative urine pregnancy test for women and no breast-feeding. 6. Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening.
Exclusion criteria
Exclusion criteria: 1. History or evidence of allergy or hypersensitivity to Enoxaparin or Low molecular weight heparins or any related drugs or any of the excipients of this product. 2. Subject Systolic B.P 100 beats per minute. 3. Serum bilirubin greater than 1.5 times of the ULRR. 4. Serum creatinine greater than 1.5 times of the ULRR. 5. Alanine amino transferase or aspartate amino transferase greater than 2 times of the ULRR. 6. Positive of hepatitis B or C virus. 7. Have more than one abnormal EKG, which is considered as clinically significant. 8. History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma. 9. Any major illness in the past 3 months or any significant ongoing chronic medical illness. 10. History of psychiatric disorder. 11. History of heparin-induced thrombocytopenia. 12. History or presence of major active bleeding or abnormal bleeding due to hemorrhoids, epistaxis, gastrointestinal ulcer or other symptoms in past 1 month before the study drug administration and until the completion of the study. 13. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 14. History of usually smoking (more than 10 cigarettes per day), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 7 days before the study drug administration and until the completion of the study. 15. High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of each period of the study. 16. Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids). 17. Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 7 days or hormonal methods of contraception within 28 days (Depo-Provera® must be discontinued at least 6 months) prior to receiving the first dose of study medication. 18. History of difficulty in accessibility of veins in left and right arm. 19. Blood donation (one unit or 450 mL) within the past 3 months before the study. 20. Participation in any clinical study within the past 3 months before the study. 21. Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameter: Anti-Xa 19 time-point Anti-Xamax, Anti-Xa AUEC0→t and Anti-Xa AUEC0→∞ ,Pharmacodynamic parameter: Anti-IIa 19 time-point Anti-IIamax, Anti-IIa AUEC0→t and Anti-IIa AUEC0→∞ | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamic parameter: Anti-Xa 19-time-point Anti-Xa: Anti-Xa T1/2, Anti-Xa Tmax, Anti-Xa AUEC0→t/Anti-Xa AUEC0→∞,Pharmacodynamic parameter: Anti-IIa 19-time-point Anti-lla T1/2, Anti-IIa Tmax, Anti-IIa AUEC0→t/Anti-IIa AUEC0→∞ | — |
Countries
Thailand
Contacts
Public ContactPreechanoot Aimruen
Siam Bioscience Co., Ltd.
Outcome results
None listed