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Bioequivalence under fasting conditions.
| PK parameter | GM and GMR | IIV% | 90%CI | ||
|---|---|---|---|---|---|
| T (N = 36) | R (N = 36) | GMR (%) | |||
| Cmax (ng/ml) | 7.820 | 7.992 | 97.84 | 26.30 | 88.26–108.46 |
| AUC0–t (h ng/ml) | 5.597 | 5.620 | 99.60 | 14.15 | 94.16–105.35 |
| AUC0–∞ (h ng/ml) | 5.740 | 5.791 | 99.12 | 14.58 | 93.55–105.01 |
GMR refers to the geometric mean ratio of the test over reference pharmacokinetic metric. IIV refers to the intraindividual variation.
