A pilot phase I, randomised, open mono-center, two parallel group clinical trial investigating the pharmacokinetics of a prolonged-release formulation in comparison to an immediate-release formulation of St. John's wort extract Ze 117 in healthy male volunteers under fasting condition.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Nuvisan GmbH
Neu-Ulm, Germany
Half Value Duration (HVD) of surrogate markers of the total extract Ze 117
Time frame: 3 days
Peak-trough fluctuation (PTF) of surrogate markers of the total extract Ze 117
Time frame: 3 days
Tmax of surrogate markers of the total extract Ze 117
Time frame: 3 days
AUCss of surrogate markers of the total extract Ze 117
Time frame: 3 days
Cmax of surrogate markers of the total extract Ze 117
Time frame: 3 days
Cmin of surrogate markers of the total extract Ze 117
Time frame: 3 days
lag time of surrogate markers of the total extract Ze 117
Time frame: 3 days
Mean Residence Time (MRT) of surrogate markers of the total extract Ze 117
Time frame: 3 days
T1/2 of surrogate markers of the total extract Ze 117
Time frame: 3 days
Half value Duration (HVD) of hyperforin
Time frame: 3 days
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