Table 3.
Bioavailability of the three tablet strengths: Study 1 point estimates and 90% CIs
| Study regimen description | Pharmacokinetic parametersa | Central valueb | Relative bioavailability | ||
|---|---|---|---|---|---|
| Test | Reference | Point estimatec | 90% CI | ||
| 2 × 50 mg tablets versus 1 × 100 mg tablet | Cmax | 0.522 | 0.557 | 0.937 | 0.852–1.031 |
| AUCt | 5.83 | 6.56 | 0.889 | 0.808–0.979 | |
| AUC∞ | 5.98 | 6.72 | 0.890 | 0.809–0.979 | |
| 10 × 10 mg tablets versus 2 × 50 mg tablets | Cmax | 0.515 | 0.522 | 0.986 | 0.896–1.085 |
| AUCt | 5.78 | 5.83 | 0.991 | 0.900–1.090 | |
| AUC∞ | 5.93 | 5.98 | 0.992 | 0.902–1.091 | |
| 10 × 10 mg tablets versus 1 × 100 mg tablet | Cmax | 0.515 | 0.557 | 0.924 | 0.840–1.017 |
| AUCt | 5.78 | 6.56 | 0.881 | 0.800–0.969 | |
| AUC∞ | 5.93 | 6.72 | 0.883 | 0.803–0.971 | |
Note: All groups were conducted under moderate-fat conditions consisting of ≤ 700 Kcal with ≤ 20% of the total caloric intake from fat
AUC∞ area under the plasma concentration–time curve from time zero to infinite time, AUCt area under the plasma concentration–time curve from time zero to time of the last measurable concentration, CIs confidence intervals, Cmax maximum observed plasma concentration
aUnits for Cmax and AUC are expressed as μg/mL and μg⋅h/mL, respectively
bAnti-logarithm of the least squares means for logarithms
cAnti-logarithm of the difference (test minus reference) of the least squares means of the logarithms