Table 3.
Analysis of bioequivalence based on the ANOVA statistical model
| Ambroxol ER retard capsule 75 mg | Ambroxol IR tablet 30 mg | Ambroxol IR effervescent tablet 60 mg | Ambroxol IR tablet 30 mg | Ambroxol ER retard capsule 75 mg | Ambroxol IR effervescent tablet 60 mg | |
|---|---|---|---|---|---|---|
| Primary endpoints | ||||||
| AUCSS 0–24, ng × h/l | ||||||
| Adjusted geometric mean | 1184.7 | 1070.4 | 1108.8 | 1072.4 | 1184.7 | 1107.9 |
| Adjusted GMR, % | 110.7 | 103.4 | 106.9 | |||
| 90% CI | 99.8, 122.7 | 96.5, 110.7 | 100.3, 114.0 | |||
| Within-participant CV, % | 20.4 | 13.5 | 12.7 | |||
| Cmax SS, nmol/l | ||||||
| Adjusted geometric mean | 73.7 | 87.0 | 90.8 | 87.4 | 73.5 | 90.9 |
| Adjusted GMR, % | 84.7 | 103.9 | 80.9 | |||
| 90% CI | 77.0, 93.3 | 95.2, 113.3 | 73.9, 88.6 | |||
| Within-participant gCV, % | 19.0 | 17.2 | 18.0 | |||
| Secondary endpoints | ||||||
| AUCSS 0–24norm, nmol × h/l | ||||||
| Adjusted geometric mean | 947.7 | 1070.4 | 1108.8 | 1072.4 | 947.8 | 1107.9 |
| Adjusted GMR, % | 88.5 | 103.4 | 85.6 | |||
| 90% CI | 79.9, 98.2 | 96.5, 110.7 | 80.2, 91.2 | |||
| Within-participant gCV, % | 20.4 | 13.5 | 12.7 | |||
| Cmax SS/AUCSS 0–24 | ||||||
| Adjusted GMR, % | 76.6 | 100.5 | 75.7 | |||
| 90% CI | 71.1, 82.4 | 94.7, 106.6 | 69.9, 81.9 | |||
| Within-participant gCV, % | 14.6 | 11.7 | 15.6 | |||
| Cmax SS/AUCSS 0–24norm | ||||||
| Adjusted GMR, % | 95.7 | 100.5 | 94.6 | |||
| 90% CI | 88.9, 103.0 | 94.7, 106.6 | 87.4, 102.4 | |||
| Within-participant gCV, % | 14.6 | 11.7 | 15.6 | |||
AUC area under the curve, CI confidence interval, CV coefficient of variation, ER extended release, GMR geometric mean ratio, IR immediate release, SS steady state