Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected subcutaneously via auto-injector in healthy male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Randomization then administration of combination product study medication according to group assignment
Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Maximum Concentration (Cmax) for Serum Testosterone and Testosterone Enanthate
Cmax = Maximum blood concentration (ng/dL) of TT=Total Testosterone and TE=Testosterone Enanthate
Time frame: Maximum serum concentrations occurring during an 8 days study window
Area Under the Concentration-time Curve From Time Zero to Time t
AUC(0-168h) (ng⋅hr/dL) = area under the concentration-time curve from time zero to Day 8 (1 week);
Time frame: 168 hrs
Area Under the Concentration-time Curve From Time Zero to Infinity
AUC(0-inf) (ng⋅hr/dL) = area under the concentration-time curve from time zero to infinity
Time frame: time zero to infinity
Time to Maximum Concentration (Tmax)(hr)
tmax = Time to reach maximum concentration
Time frame: The sample time of Cmax during a 168 hour sampling interval
Half-life (t 1/2)(hr)
t 1/2 = Half-life is the time required for a concentration to reduce to half its initial value
Time frame: 168 hours
Clearance CL/F (L/hr)
Clearance - volume of plasma from which TT/TE is completely removed per unit time
Time frame: 168 hours
Vd/F (L)
Vd/F (L) = Apparent volume of distribution
Time frame: 168 hours
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