Table 2.
Comparative bioavailability
| Plasma PK parameter | DCF100C1 (1%) vs. Voltaren®Emulgel® | DCF100C2 (1%) vs. Voltaren®Emulgel® | DCF100C1 (2.5%) vs. Voltaren®Emulgel® | DCF100C2 (2.5%) vs. Voltaren®Emulgel® | |
|---|---|---|---|---|---|
| AUC(0,10 h) | PE | 284.02% | 282.38% | 468.62% | 480.19% |
| 90% CI | 201.76, 399.82% | 199.34, 400.00% | 331.01, 663.43% | 337.17, 683.88% | |
| Cmax | PE | 334.91% | 349.51% | 595.97% | 571.14% |
| 90% CI | 215.12, 521.40% | 222.69, 548.54% | 380.01, 934.65% | 361.38, 902.65% | |
| MD i.m. PK parameter | |||||
|---|---|---|---|---|---|
| AUC(0,10 h) | PE | 128.83% | 212.55% | 131.74% | 270.57% |
| 90% CI | 42.24, 392.95% | 81.58, 553.77% | 47.82, 362.96% | 99.27, 737.46% | |
| Cmax | PE | 113.65% | 190.97% | 156.11% | 258.43% |
| 90% CI | 43.32, 298.14% | 83.42, 437.15% | 64.98, 375.04% | 108.57, 615.12% | |
| MD s.c. PK parameter | |||||
|---|---|---|---|---|---|
| AUC(0,10 h) | PE | 60.67% | 59.79% | 53.56% | 95.29% |
| 90% CI | 23.13, 159.12% | 23.84, 149.98% | 21.40, 134.03% | 36.85, 246.38% | |
| Cmax | PE | 72.84% | 74.70% | 70.39% | 97.84% |
| 90% CI | 34.93, 151.90% | 37.06, 150.57% | 34.98, 141.62% | 47.43, 201.84% | |
Results are given as 90% confidence intervals for: test reference ratios (point estimators) of geometric means for AUC(0,10 h) and Cmax. Total plasma and free non-protein bound tissue concentrations are given. PE, point estimator (ratio of geometric means).