Study # Test Article Formulation Route Dose (mg/kg) Cmax (ng/mL) Tmax (hr) T1/2 (hr) AUClast (hr*ng/mL) CL (ml/hr/kg) Vss (mL/kg) F (%)
Study 1 [I-125]Peptide A IR IV 0.5 9638 ± 403 NA 2.9 ± 2.2 15757 ± 2628 30 ± 6 68 ± 15 NA
Study 2 Peptide A IR SC 2 1835 ± 528 1.3 ± 0.6 4.7a 9653±4093 NA NA 15
Study 3 Peptide A CR SC 2 9638 ± 403 10 ± 12 10a 5506 ± 1144 NA NA 8.7358
aN=1, t1/2 was not able to be determined from other two animals due to an incomplete PK profile. F% (bioavailability) is calculated by (AUClast, SC/Dose,SC)/(AUClast, IV/Dose,IV)
Table 2: Rat PK parameters after IV and SC administration (n = 3)
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