Table 3.
Plasma TA pharmacokinetic parameters following intra-articular administration of TA-ER (32 mg) or TAcs (40 mg) to the index joint of adult patients with symptomatic shoulder OA (PK Population)
| Parameter | N | TA-ER 32 mg | N | TAcs 40 mg |
|---|---|---|---|---|
| Cmax, GM (95% CI), pg/mL | 12 | 1282.7 (963.02–1708.38) | 13 | 2034.4 (1098.17–3768.83) |
| AUC0–last, GM (95% CI), h × pg/mL | 12 | 557,602.1 (427,051.32–728,062.54) | 13 | 873,543.2 (615,704.94–1,239,356.10) |
| AUC0–24, GM (95% CI), h × pg/mL | 12 | 23,246.5 (16,825.70–32,117.57) | 13 | 36,075.6 (19,736.15–65,942.40) |
| AUC0–96, GM (95% CI), h × pg/mL | 12 | 85,740.3 (62,183.45–118,221.04) | 13 | 132,648.4 (79,655.23–220,896.80) |
| AUC0–∞, GM (95% CI), h × pg/mL | 11 | 625,590.9 (461,835.32–847,410.32) | 11 | 1,061,253.7 (811,387.53–1,388,065.85) |
| tmax, median (range), h | 12 | 4 (1–57) | 13 | 8 (2–1973) |
| t(1/2) median (range), h | 11 | 613 (287–1026) | 11 | 676 (267–1187) |
| CL, GM (95% CI), h × mL/kg | 11 | 51.2 (37.76–69.29) | 11 | 37.7 (28.82–49.30) |
| MRT, GM (95% CI), h | 11 | 838.6 (622.51–1129.58) | 11 | 832.4 (635.60–1090.16) |
AUC area under the plasma concentration-time curve, CI confidence interval, CL drug clearance, Cmax maximum plasma concentration, GM geometric mean, MRT mean residence time, TAcs triamcinolone acetonide crystalline suspension, TA-ER triamcinolone acetonide extended-release, t1/2 half-life, tmax time to maximum plasma concentration.