Table 5.
Pharmacokinetic parameters over eight hours with two formulations, Brufen® (reference) and Dolaraz® (test) after a single oral dose of 100 mg formulation in 24 healthy adult male volunteers
| Parameter | Reference mean (±SD) | Test (Mean ± SD) |
|---|---|---|
| AUC0–∞ μg/mL/hour | 31.79 (10.60) | 29.69 (9.79) |
| AUC0–t μg/mL/hour | 28.17 (8.12) | 27.21 (9.01) |
| Cmax μg/mL | 9.92 (2.13) | 10.05 (1.84) |
| Tmax, hours | 0.80 (0.42) | 0.90 (0.58) |
| Ke | 0.31 (0.22) | 0.36 (0.23) |
| T1/2, hours | 2.98 (1.37) | 2.44 (1.19) |
Abbreviations: AUC0–∞, area under the curve extrapolated to infinity; AUC0–t, area under the curve to the last measurable concentration; Cmax, peak plasma concentration; Tmax, time to peak concentration; T1/2, elimination half-life; Ke, elimination rate constant.