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Table 3 Summary of the analysis of plasma PK parameters (Japanese vs Caucasian) on Day 1 and Day 14

From: Pharmacokinetics of indacaterol, glycopyrronium and mometasone furoate administered as an inhaled fixed-dose combination in Japanese and Caucasian healthy subjects

 

Day 1

Day 14

Adjusted geometric mean

Adjusted geometric mean ratio (90% CI) (Japanese/Caucasian)

Adjusted geometric mean

Adjusted geometric mean ratio (90% CI) (Japanese/Caucasian)

Treatment

PK parameter (unit)

Japanese

Caucasian

Japanese

Caucasian

Analyte: indacaterol

 IND/GLY/MF high-dose

Cmax (pg/mL)

327

(n = 13)

269

(n = 15)

1.22 (1.05, 1.41)

586

(n = 14)

447

(n = 15)

1.31 (1.13, 1.51)

AUC0–24 h (h × pg/mL)

989

(n = 13)

877

(n = 15)

1.13 (0.971, 1.31)

3190

(n = 14)

2730

(n = 15)

1.17 (1.01, 1.35)

 IND/GLY/MF medium-dose

Cmax (pg/mL)

374

(n = 15)

263

(n = 16)

1.42 (1.24, 1.63)

578

(n = 16)

446

(n = 16)

1.30 (1.13, 1.49)

AUC0–24 h (h × pg/mL)

1070

(n = 15)

836

(n = 16)

1.28 (1.11, 1.48)

3250

(n = 16)

2680

(n = 16)

1.21 (1.05, 1.40)

Analyte: glycopyrronium

 IND/GLY/MF high-dose

Cmax (pg/mL)

267

(n = 14)

185

(n = 15)

1.45 (1.16, 1.81)

424

(n = 14)

308

(n = 15)

1.38 (1.13, 1.69)

AUC0–24 h (h × pg/mL)

270

(n = 14)

263

(n = 15)

1.02 (0.860, 1.22)

739

(n = 14)

702

(n = 15)

1.05 (0.920, 1.20)

 IND/GLY/MF medium-dose

Cmax (pg/mL)

279

(n = 16)

185

(n = 16)

1.51 (1.22, 1.87)

437

(n = 16)

284

(n = 16)

1.54 (1.27, 1.87)

AUC0–24 h (h × pg/mL)

285

(n = 16)

260

(n = 16)

1.10 (0.925, 1.30)

755

(n = 16)

712

(n = 16)

1.06 (0.929, 1.21)

Analyte: mometasone furoate

 IND/GLY/MF high-dose

Cmax (pg/mL)

195

(n = 14)

193

(n = 15)

1.01 (0.920, 1.11)

264

(n = 14)

247

(n = 15)

1.07 (0.969, 1.18)

AUC0–24 h (h × pg/mL)

1700

(n = 14)

1600

(n = 15)

1.07 (0.964, 1.18)

2520

(n = 14)

2180

(n = 15)

1.15 (1.05, 1.27)

 IND/GLY/MF medium-dose

Cmax (pg/mL)

104

(n = 16)

96.3

(n = 16)

1.08 (0.990, 1.18)

139

(n = 16)

121

(n = 16)

1.15 (1.04, 1.26)

AUC0–24 h (h × pg/mL)

926

(n = 16)

784

(n = 16)

1.18 (1.07, 1.30)

1260

(n = 16)

1030

(n = 16)

1.23 (1.12, 1.34)

  1. Model: log (pk) = ethnic group + sequence + period + treatment + ethnic group * treatment, with random effects for subject and matched pair. Covariates were not included in this analysis. IND/GLY/MF medium-dose, IND/GLY/MF 150/50/80 μg o.d; IND/GLY/MF high-dose, IND/GLY/MF 150/50/160 μg o.d. AUC, area under curve; Cmax, maximum plasma concentration; IND/GLY/MF, indacaterol/glycopyrronium/mometasone. N varies across treatments and ethnicities based on treatment discontinuations during the study as described under study participants. For two Japanese subjects (one profile for the high dose treatment and one profile for the medium dose treatment) for whom pre-dose indacaterol concentration on Day 1 was missing, Day 1 PK parameters were excluded from primary analysis