Primary Objective: Evaluation of the pharmacokinetic equivalence of two Docetaxel formulations in terms of AUC and Cmax.
Comparison of pharmacokinetic parameters (T1/2β, CL, Vdss) Safety as measured by adverse events
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
70 mg/m2 for age of ≥ 65
Inje Pusan paik University hospital
Pusan, Jin-Gu, South Korea
Pharmacokinetics of SYP-0704A and Taxotere in terms of AUC
Time frame: 3 months
Pharmacokinetics of the T1/2 of SYP-0704A and Taxotere
Time frame: 3 months
Pharmacokinetics of the CL of SYP-0704A and Taxotere
Time frame: 3 months
Pharmacokinetics of the Vdss of SYP-0704A and Taxotere
Time frame: 3 months
Number of paticipants with Adverse Events
Time frame: 3months
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