Parameter | Product | GM | GM, 95% CI | GMR (Test vs Reference), % | GMR, 90% CI | Pseudo Intra-participant % CVb |
---|---|---|---|---|---|---|
AUC0-t, ng.hour/mL | Test | 200,000 | 184,000–217,000 | 108.01 | 105.08-111.03 | 6.9 |
Reference | 185,000 | 170,000–201,000 | - | - | - | |
AUC0-inf, ng.hour/mL | Test | 244,000 | 219,000–272,000 | 106.12 | 102.62–109.75 | 8.4 |
Reference | 230,000 | 206,000–257,000 | - | - | - | |
Cmax, ng/mL | Test | 5,830 | 5,450–6,230 | 116.89 | 113.66–120.22 | 7.0 |
Reference | 4,990 | 4,680–5,320 | - | - | - |