TABLE 1

Mean (± S.E.) systemic serum pharmacokinetic parameters for [2H]-TU, [2H]-T, and [2H]-DHT determined after a 10-min i.v. infusion (3.91 mg) of [2H]-TU to dogs that simultaneously received an oral dose of 80 mg of TU administered as either Andriol (n = 4) or Andriol Testocaps (n = 4)


Compound

i.v. Parameter

Oral Andriol Group (n = 4)

Oral Andriol Testocaps Group (n = 4)

p Valuea

Combined i.v. Datab (n = 8)
[2H]-TU Cmax (nM) 1,250 ± 116 1,217 ± 77 0.81 1,234 ± 65
AUC0-∞ (nM · min) 36,137 ± 3,835 36,720 ± 2,089 0.90 36,429 ± 2,024
t1/2 (min) 15.2 ± 0.7 16.4 ± 0.7 0.25 15.8 ± 0.5
CL (l/min) 0.228 ± 0.022 0.218 ± 0.012 0.70 0.222 ± 0.012
VD (l) 4.98 ± 0.50 5.17 ± 0.44 0.78 5.08 ± 0.31
[2H]-T Cmax (nM) 74.3 ± 6.5 81.1 ± 5.3 0.44 77.7 ± 4.1
tmax (min) 25 ± 5 26 ± 4 0.90 26 ± 3
AUC0-∞ (nM · min) 5,187 ± 452 5,746 ± 261 0.33 5,466 ± 264
t1/2 (min) 32.3 ± 4.5 31.8 ± 3.5 0.93 32.1 ± 2.7
[2H]-DHT Cmax (nM) 6.3 ± 1.3 9.3 ± 1.4 0.16 7.8 ± 1.1
tmax (min) 42 ± 11 37 ± 6 0.68 49 ± 6
AUC0-∞ (nM · min) 418 ± 73 760 ± 145 0.08 589 ± 99

t1/2 (min)
38.7 ± 11.7
36.3 ± 4.7
0.86
37.5 ± 5.8
  • a p values are the result of the two-tailed Student's t test of the mean parameter estimates between the two formulations.

  • b The mean ± S.E. values for all study dogs (n = 8) was calculated because there was no statistically significant difference (p > 0.05) between Andriol and Andriol Testocaps for any of the measured parameters.