Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy M… (NCT01561417) | Clinical Trial Compass
CompletedPhase 1
Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
France28 participantsStarted 2006-04
Plain-language summary
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).
Who can participate
Age range18 Years – 45 Years
SexMALE
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Inclusion Criteria:
* Caucasian
* Body Mass Index (BMI) between 18 and 27 kg/m\^2, both inclusive
* Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
* Smoke less than 10 cigarettes (or equivalent) per day
* Capable of giving written Informed Consent (IC)
Exclusion Criteria:
* Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
* Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
* Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
* Overt bleeding, including from gastrointestinal tract
* Hepatitis (B or C) infection
* HIV (human immunodeficiency virus) infection
What they're measuring
1
Area under the plasma concentration versus time curve for FVIIa clot activity