Viatris Pharmaceuticals LLC

The aim of this study was to demonstrate that the exposure of tofacitinib MR 11 mg QD and IR 5 mg twice daily (12h apart) was equivalent after a single dose and at steady state. The pharmacokinetic differences of tofacitinib ER formulation compared with tofacitinib IR formulation after a single dose and at steady state, as well as its safety and tolerability in Chinese healthy volunteers were evaluated.

1. To evaluate the efficacy of pregabalin (300 - 450 mg/day) twice daily compared with placebo in relieving fibromyalgia-related pain symptoms; 2. If the first study objective is achieved, the second primary study objective is to evaluate the efficacy of pregabalin (twice daily) compared with placebo in the treatment of fibromyalgia (pain reduction, patient global assessment and functional improvement).