Table 3. Bioequivalence assessment results of the OSF and CT under fasting and fed conditions.
| Parameters | GM (OSF) | GM (CT) | GMR (OSF/CT; %) | 90% CI (%) | CV (%) | Power (%) |
|---|---|---|---|---|---|---|
| OSF without water vs. CT with water under fasting conditions (n=29) | ||||||
| Cmax (ng/mL) | 290.02 | 277.21 | 104.62 | 99.47–110.04 | 11.34 | 100.00 |
| AUC0–t (h·ng/mL) | 1,878.30 | 1,853.70 | 101.33 | 98.06–104.70 | 7.33 | 100.00 |
| AUC0–∞ (h·ng/mL) | 1,941.37 | 1,912.40 | 101.51 | 98.11–105.70 | 7.64 | 100.00 |
| OSF with water vs. CT with water under fasting conditions (n=29) | ||||||
| Cmax (ng/mL) | 294.14 | 277.21 | 106.11 | 100.88–111.60 | 11.34 | 99.99 |
| AUC0–t (h·ng/mL) | 1,813.64 | 1,853.70 | 97.84 | 94.69–101.10 | 7.33 | 100.00 |
| AUC0–∞ (h·ng/mL) | 1,864.89 | 1,912.40 | 97.52 | 94.24–100.90 | 7.64 | 100.00 |
| OSF vs. CT under fed conditions (n=30) | ||||||
| Cmax (ng/mL) | 151.39 | 166.79 | 90.77 | 84.32–97.71 | 16.89 | 88.51 |
| AUC0–t (h·ng/mL) | 1,723.91 | 1,773.51 | 97.20 | 94.54–99.94 | 6.34 | 100.00 |
| AUC0–∞ (h·ng/mL) | 1,771.23 | 1,839.42 | 96.29 | 99.30–99.38 | 5.82 | 100.00 |
Analysis of variance on log-transformed Cmax, AUC0–t, and AUC0–∞ was used to analyze the bioequivalence between OSF and CT. The fixed factors included sequence, period, and drug. The random factor was the subject. OSF, oral soluble film; CT, chewable tablet; GM, geometric mean; GMR, geometric mean ratio; CI, confidence interval; CV, coefficient of variation; power, power of test; Cmax, maximum plasma drug concentration; AUC0–t, area under the plasma drug concentration-time curve from t=0 to the last quantifiable concentration; AUC0–∞, area under the plasma drug concentration-time curve from t=0 to infinity.