PK or PD

Parameter

Mean ± SE

P Value (RHIIP vs Actrapid®)

RHIIP (N = 30)

Actrapid® (N = 30)

PK (Insulin)

Cmax (ng/mL)

1.8 ± 0.25

0.8 ± 0.05

0.0006

Tmax (min)

86 ± 10

141 ± 12

0.0017

AUC(0-10hr) (ng/mL)min

411 ± 57

198 ± 11

0.0013

Relative BA (%)

12.0±1.80

100

N/A

PD (GIR)

GIRmax (mg/kg/min)

8.4 ± 0.9

7.6 ± 0.5

0.3051

TmaxGIR (min)

173 ± 13

218 ± 9

<0.0001

AUC(0-10hr) (mg/kg)

2734 ± 274

2482 ± 155

0.3257

Relative BP (%)

6.3±0.63

100

N/A
Table 2: Pharmacokinetic (PK) and pharmacodynamic (PD) parameters of insulin (baseline subtracted) following inhalation of RHIIP or subcutaneous administration of Actrapid®.
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