To determine the tolerability and safety of Pharmaton PHL 00747 soft gelatine capsules and film-coated tablets
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
203
Incidence of total drug-related adverse events assessed by the investigator
Time frame: up to 30 days
Incidence of all adverse events
Time frame: up to 30 days
Changes from baseline in laboratory tests including Quick's test, activated partial thromboplastin time (aPTT) and cholesterol (total, HDL, LDL)
Time frame: up to 44 days
Changes from baseline in vital signs (blood pressure and heart rate)
Time frame: up to 30 days
Overall tolerability assessed by the subject and the investigator on a four-point rating scale
Time frame: day 30
Overall acceptance of the medications (taste and after taste) by the subject on a four-point rating scale
Time frame: day 30
Tolerability of the trial medications by the subject
Time frame: up to 30 days
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