A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements

No investigational product was administered to any subject in this study.

Inclusion criteria

• Signed and dated, written informed consent (Institutional Review Board [IRB]-approved informed consent form [ICF]).
• Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

Exclusion criteria

• Healthy subjects who do not conform to the above inclusion criteria.
• Healthy subjects who cannot communicate reliably with the Investigator.
• History of major bleeding or major trauma within the past 6 months
• Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
• Significant infection or known inflammatory process within 2 weeks of screening.
• Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
• Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin [ASA]) with a direct effect on hemostasis within 7 days of testing
• Unwillingness or inability to comply with procedures required in this protocol.
• Subjects who are concurrently enrolled in any other clinical study.