Table 1.
Main pharmacokinetic parameters for diclofenac obtained in plasma (total drug) and subcutaneous and skeletal muscle tissue (free drug) of the thigh in 12 healthy males after the final dose of a 3-day multiple dose regimen of either topical application of MIKA Diclofenac Spray Gel 4% or oral administration of VOLTAREN® 50 mg enteric coated tablets
| Topical | Oral | |||
|---|---|---|---|---|
| Median | 95% CI | Median | 95% CI | |
| Plasma (n = 12) | ||||
| AUC∞, AUCτ (ng h mL−1) | 32.8 | (22.7–52.9) | 1569.7 | (1255.8–1849.8) |
| Cmax (ng mL−1) | 4.9 | (3.4–7.7) | 1240.2 | (787.0–1388.9) |
| Subcutaneous tissue (n = 12) | ||||
| AUC∞, AUCτ (ng h mL−1) | 21.5 | (19.4–50.5) | 8.6 | (7.0–10.6) |
| Cmax (ng mL−1) | 13.1 | (9.3–33.6) | 1.9 | (1.6–2.5) |
| Skeletal muscle (n = 12) | ||||
| AUC∞, AUCτ (ng h mL−1) | 18.2 | (11.8–28.1) | 8.8 | (7.8–12.3) |
| Cmax (ng mL−1) | 12.3 | (6.2–22.0) | 2.6 | (2.0–4.0) |
AUC∞, AUCτ[ng h mL−1], Area under the plasma or tissue concentration vs. time curve of diclofenac approximated to infinity (AUC∞) or evaluated in the last dosage interval (0–8 h; AUCτ); Cmax[ng mL−1], Maximal plasma or tissue concentration.