Table 3.
Bioequivalence testing on the main analytes for the comparison of different meal compositions with meal C (reference)
| Analyte | Parameter (units) | Point estimate | 90% CI | Conclusion* |
|---|---|---|---|---|
| Meal A (test) vs. meal C (reference) | ||||
| Testosterone | Cmax (nmol/l) | 0·17 | 0·14–0·21 | Not bioequivalent |
| AUC0–tlast (nmol h/l) | 0·21 | 0·18–0·25 | Not bioequivalent | |
| DHT | Cmax (nmol/l) | 0·22 | 0·18–0·27 | Not bioequivalent |
| AUC0–tlast (nmol h/l) | 0·15 | 0·12–0·19 | Not bioequivalent | |
| Meal B (test) vs. meal C (reference) | ||||
| Testosterone | Cmax (nmol/l) | 0·26 | 0·21–0·33 | Not bioequivalent |
| AUC0–tlast (nmol h/l) | 0·30 | 0·25–0·35 | Not bioequivalent | |
| DHT | Cmax (nmol/l) | 0·29 | 0·24–0·36 | Not bioequivalent |
| AUC0–tlast (nmol h/l) | 0·23 | 0·18–0·29 | Not bioequivalent | |
| Meal D (test) vs. meal C (reference) | ||||
| Testosterone | Cmax (nmol/l) | 0·99 | 0·79–1·25 | Indeterminant |
| AUC0–tlast (nmol h/l) | 1·06 | 0·89–1·25 | Bioequivalent | |
| DHT | Cmax (nmol/l) | 0·99 | 0·80–1·22 | Bioequivalent |
| AUC0–tlast (nmol h/l) | 1·16 | 0·90–1·49 | Indeterminant | |
Bioequivalent: the 90% confidence interval (CI) is inside the acceptance range of 0·80–1·25. Not bioequivalent: the 90% CI is outside the acceptance range and the effect is statistically significant (P = 0·05). Indeterminant: the 90% CI is outside the acceptance range and the effect is not statistically significant (P > 0·05).