Healthy Clinical Trial
Official title:
Demonstration of Pharmacodynamic Equivalence of Enoxaparin Rovi (100-mg Subcutaneous Injection) to Clexane® (100-mg Subcutaneous Injection) in Healthy Volunteers
Verified date | December 2017 |
Source | Rovi Pharmaceuticals Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To demonstrate the pharmacodynamic (PD) equivalence of enoxaparin Rovi (100 mg/mL) 100-mg SC
injection to Clexane® (100 mg/mL) 100-mg SC injection in healthy volunteers.
As secondary objective, to evaluate the safety and tolerability of enoxaparin Rovi (100
mg/mL) in healthy volunteers.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 1, 2015 |
Est. primary completion date | December 1, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Subject provides informed consent (approved by an Independent Ethical Committee (IEC)) before any study specific evaluation is performed. 2. Subject is between the ages of 18 and 45 years, inclusive. 3. All female subjects must have a negative pregnancy test at Screening and upon check-in to the clinic. 4. Women of childbearing potential must use or have used one of the following acceptable birth control methods: Surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) for at least 6 months before the first dose of study drug;Intrauterine device in place for at least 3 months before the first dose of study drug; or barrier method (condom, diaphragm) for at least 21 days before the first dose of study drug and throughout the study. 5. Subject has a body mass index between 18 and 30 kg/m2, inclusive. 6. Subject is able and willing to abstain from alcohol from 48 hours before the first dose of study drug through the end of the study. 7. Subject has no clinically significant abnormalities in medical history, vital sign measurements, or physical examination findings. 8. Subject has computerized 12-lead electrocardiogram (ECG) results showing no signs of clinically relevant pathology or deviations, as judged by the investigator. 9. Subject has hematology, serum chemistry, coagulation, and urinalysis test results within the reference ranges (Hb =7.5 mmol/L and =8.5 mmol/L for female and male, respectively) or showing no clinically relevant deviations, as judged by the investigator. Thrombocytes at screening have to be within the normal range. 10. Subject is a nonsmoker or has quit smoking at least 6 months before the first dose of study drug. Exclusion Criteria: Subjects are excluded from the study if any of the following criteria are met: 1. Subject has active or recurring clinically significant skin, head, ears, eyes, nose, throat, respiratory, cardiovascular, gastrointestinal, endocrine/metabolic, genitourinary, neurologic, hematologic, musculoskeletal, immunologic, allergic, psychological/psychiatric, or other disease requiring medical treatment. 2. Female subject with weight < 45 kg or male subject with weight < 57 kg. 3. Subject is a woman who is pregnant or breastfeeding. 4. Subject has systolic blood pressure greater than 150 mm Hg or diastolic blood pressure greater than 90 mm Hg at Screening (confirmed upon repeat measurement). 5. Subject has a calculated (Cockroft & Gault formula) creatinine clearance less than 80 mL/minute and the value does not return to within reference range upon retest. 6. Subject has Hb <7.5 mmol/L and <8.5 mmol/L for female and male, respectively. 7. Subject has an active malignancy of any type other than nonmelanomatous skin malignancies. 8. Subject has any history of alcohol abuse or drug addiction. 9. Subject has any history of relevant drug and/or food allergies. 10. Subject has used an investigational drug within 60 days before the first dose of study drug. 11. Subject has used any prescription drugs (with special attention to antiplatelet or anticoagulant medication, eg, acetyl salicylic acid, NSADs, clopidogrel, warfarin, acenocumarol, heparin, low molecular weight heparin, dabigatran, rivaroxaban, apixaban) or over-the-counter medication that may affect coagulation (including aspirin or NSAIDs) within 4 weeks before dosing, or any other over-the-counter medication (including vitamins, herbal supplements, or dietary supplements) within 2 weeks before dosing. 12. Subject has donated or lost 550 mL or more of blood (including plasmapheresis) within 60 days before the first dose of study drug. 13. Subject has a positive test result for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, oxycodone), cotinine, or alcohol. 14. Subject has a positive test result for human immunodeficiency virus (1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody. 15. Subject has any illness within 5 days before the first dose of study drug. 16. Subject has a positive test for fecal occult blood at Screening. 17. Subject has any history and/or current conditions of bleeding tendency such as: active bleeding, known bleeding diathesis or hemostatic defects due to severe hepatic or renal disease; recent gastrointestinal or genitourinary bleeding (10 days before study entry) women of child-bearing potential with normal cyclic bleeding which is not considered as heavy menstruation by the investigator, are allowed for inclusion; diabetic hemorrhagic retinopathy, or other hemorrhagic ophthalmic conditions. 18. Subject has a known history or family history of any relevant congenital or acquired coagulation disorder (eg, hemophilia, von Willebrand-Jürgens syndrome, or activated protein C resistance based upon Factor V Leiden mutation). 19. Subject has a history of thrombocytopenia, including heparin induced thrombocytopenia. 20. Subject has a known history of hypersensitivity to drugs with a similar chemical structure to enoxaparin sodium (eg, unfractionated heparin, low molecular weight heparin) or to pork products. 21. Subject is a member of the professional or ancillary personnel involved in the study. 22. Subject is deemed not suitable for entry into the study in the opinion of the investigator. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rovi Pharmaceuticals Laboratories | PRA Health Sciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AUEC0-inf for anti-FXa | area under the effect curve (AUEC) from time 0 to infinity, for anti-FXa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Primary | AUEC0-T for anti-FXa and anti-FIIa | area under the effect curve (AUEC) from time 0 to the last measured activity (T), for anti-FXa and anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Primary | Amax for anti-FXa and anti-FIIa | peak effect for anti-FXa activity (anti-FXamax), and anti-FIIa activity (anti-FIIamax) | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | RAUEC | ratio of AUEC0-T of anti-FXa to anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Amax for TFPI levels | peak effect activity (Amax) forTissue factor pathway inhibitor (TFPI) | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | AUEC0-T for TFPI levels | Area under the effect curve (AUEC) from time 0 to the last measured activity (T) forTissue factor pathway inhibitor (TFPI) | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | AUEC0-inf for TFPI levels | Area under the effect curve (AUEC) from time 0 to infinity forTissue factor pathway inhibitor (TFPI) | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Tmax for anti-FXa and anti-FIIa | time of observed maximum measured plasma activity for anti-FXa and anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | t1/2 for anti-FXa and anti-FIIa | apparent first order terminal elimination half-life for anti-FXa and anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | CL/F for anti-FXa and anti-FIIa | apparent plasma clearance after extravascular administration for anti-FXa and anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | MRT for anti-FXa and anti-FIIa | mean residence time for anti-FXa and anti-FIIa | Day -1 (Periods 1 and 2), before dosing (Pre-dose), and between 0.5 and 36 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Adverse Events (AEs) | All treatment emergent AEs (TEAEs), relationship of TEAEs to study drug, severity of TEAEs, treatment emergent serious AEs, relationship of treatment emergent serious AEs to study drug, and TEAEs leading to study drug discontinuation. The frequency of TEAEs will be summarized by system organ class and preferred term | from Informed Consent signature until 14 days after the last study drug administration (independently of the period) | |
Secondary | hematology | clinical laboratory results | at Screening, Day -1 (Period 1 only), and Day 3 (Period 2 only) and at the follow up visit (Day 7 of Period 2 only) | |
Secondary | Serum chemistry | measurements of a variety of compounds in the serum layer of blood | at Screening, Day -1 (Period 1 only), and Day 3 (Period 2 only) and at the follow up visit (Day 7 of Period 2 only) | |
Secondary | Coagulation | Prothrombin time (reported in seconds) and activated partial thromboplastin time (aPTT) | at Screening, Day -1 (Period 1 only), and Day 3 (Period 2 only) and at the follow up visit (Day 7 of Period 2 only) | |
Secondary | Urianalysis | measurements of a variety of compounds in urine | at Screening, Day -1 (Period 1 only), and Day 3 (Period 2 only) and at the follow up visit (Day 7 of Period 2 only) | |
Secondary | Blood presure | systolic and diastolic blood presure recorded after the subject had been resting for at least 5 minutes | at Screening, Day -1 (Period 1 only), and before dosing (Pre-dose) and 0.5 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Pulse rate | recorded after the subject had been resting | at Screening, Day -1 (Period 1 only), and before dosing (Pre-dose) and 0.5 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Respiratory rate | measured subsequently to pulse rate | at Screening, Day -1 (Period 1 only), and before dosing (Pre-dose) and 0.5 hours after dosing on Day 1 (Periods 1 and 2) | |
Secondary | Tympanic temperature | measured subsequently to pulse rate | at Screening, Day -1 (Period 1 only), and before dosing (Pre-dose) and 0.5 hours after dosing on Day 1 (Periods 1 and 2) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |