administration in the fasting state.  The dosage strength used is the highest proposed dosage strength of this product.  The full study review can be found in the Appendix, Section 6.2.2.  This was a single dose, randomized, 2-period, 2-treatment, 2-sequence crossover study.  The study was completed in 31 healthy subjects (23 M/8 F; mean age 31.8 (21-46) years of age).  The plasma concentration time course and pertinent pharmacokinetic parameters are shown in the Figures and Table below.

 

Stamped Appears this Way on Original

 

Appears this Way on Original

 

 

 

 

21

 

 

 

 

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