NCT01082406CompletedPhase 1
A Single Centre, Randomised, Double-blind, Cross-over Trial in Healthy Male Subjects Investigating Bioequivalence and Pharmacokinetics of rFXIII (Avecia DS) to rFXIII (Novo Nordisk DS)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
Study Overview
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Body Mass Index (BMI) between 18.5 and 30 kg/m2
- •Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
- •Non-smokers
Exclusion Criteria
- •Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
- •Blood transfusion within 3 months of trial start
- •Positive for hepatitis B or C infection
- •Positive for Human Immunodeficiency Virus (HIV) infection
- •Excessive consumption of a diet deviating from a normal diet as judged by the physician
- •Blood or plasma donation within the last 3 months prior to trial start
- •Subjects with any history of migraine
Arms & Interventions
Trial part 1
Experimental
Intervention: catridecacog (Drug)
Trial part 2
Experimental
Intervention: recombinant factor XIII (Drug)
Outcomes
Primary Outcomes
Plasma concentration-time curve (Area under Curve 0-28 days) for factor XIII activityfor both drug substances measured by the Berichrom® assay
Time Frame: after 4 weeks of treatment
Secondary Outcomes
- Number of adverse events (serious and non-serious)(over 8 weeks of treatment)
Investigators
Study Sites (1)
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