The primary objective of this study is to determine whether the test product, mercaptopurine oral 100 mg/5 mL suspension, and the reference product, Purinethol® 50 mg tablets are bioequivalent. For this purpose the PK profile of 6-mercaptopurine (6-MP) will be compared after administration of a single dose of each of the two formulations, under fasting conditions. The secondary objective is to assess the safety and tolerability of the test product, mercaptopurine oral 100 mg/5 mL suspension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
50mg
50mg
Parexel International, Bloemfontein Early Phase Clinical Unit
Bloemfontein, South Africa
Bioequivalence
At each treatment period, pharmacokinetic blood samples will be collected through the indwelling venous cannula at the following times: pre-dose and post-dose at 0.17, 0.33, 0.5, 0.75, 1.0, 1.33, 1.67, 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0 and 12.0 hours. The primary outcome measures will be * Maximum observed plasma concentration (Cmax). * AUC time zero to time of the last quantifiable concentration (AUC(0-t)) * Area under the plasma concentration versus time data pairs, with extrapolation to infinity (AUC(0-∞)).
Time frame: Within 7 days
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