Single-dose, randomized, double-blind, two-way crossover study for the demonstration of pharmacodynamic equivalence of enoxaparin (100 mg/mL) 100-mg subcutaneous injection. Manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg subcutaneous injection manufactured by Sanofi (EU) in healthy volunteers.

Single-dose, randomized, double-blind, two-way crossover study for the demonstration of pharmacodynamic equivalence of enoxaparin (100 mg/mL) 100-mg subcutaneous injection. Manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg subcutaneous injection manufactured by Sanofi (EU) in healthy volunteers. - Rovi Enoxaparin Clexane bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42485

Enrollment

Registered

2015-09-15

Start date

2015-09-25

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To treat or prevent a type of blood clot called deep vein thrombosis.

Interventions

During the study you will receive a single dose of enoxaparin manufactured by the Sponsor and a single dose of Clexane®, both after an overnight fast (at least 10 hours no eating and drinking) as a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy male or female. - Between 18 and 45 years of age, inclusive. - BMI is between 18 and 30 kilograms/meter2 - If you are a woman, your weight is > 45 kg, if you are a man, your weight is > 57 kg - Nonsmoker

Exclusion criteria

Exclusion criteria: 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. Subject is a woman who is pregnant or breastfeeding. 3. 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). 4. 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. 5. Subject has Hb

Design outcomes

Primary

Measure	Time frame
The primary objective is to demonstrate the pharmacodynamic (PD) equivalence of enoxaparin (100 mg/mL) 100-mg SC injection manufactured by Rovi (Spain) to Clexane (100 mg/mL) 100-mg SC injection manufactured by Sanofi (EU) in healthy volunteers.	—

Secondary

Measure	Time frame
The secondary objective is to evaluate the safety and tolerability of enoxaparin (100 mg/mL) 100-mg SC injection manufactured by Rovi, Spain in healthy volunteers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)