Table 3.
Summary of oral TU and topical-T NaF-EDTA plasma total testosterone (T) pharmacokinetic parameters by treatment
| Oral TU (All Doses) | Topical-T (All Doses) | |||||||
|---|---|---|---|---|---|---|---|---|
| Visit | PK Parameter | Units | N | Mean | SD | N | Mean | SD |
| Baseline | Plasma T | ng/dL | 165 | 206.8 | 80.72 | 54 | 202.7 | 91.82 |
| Final day | Cavg24a | ng/dL | 151 | 402.5d | 127.72 | 48 | 383.0 | 131.36 |
| Cmax24 | ng/dL | 151 | 1008.3 | 581.04 | 48 | 664.0 | 319.23 | |
| Tmax-amb,c | h | 155 | 3.87 | (0.00, 12.08) | 48 | 4.01 | (0.00, 24.00) | |
| Tmax-pmb | h | 151 | 16.00 | (12.00, 24.02) | ||||
Abbreviations: AM, morning; Cavg24, time-weighted average plasma T concentration AM and PM doses combined; Cmax24, mximum observed T concentration AM and PM doses combined; Cmax-AM, time-weighted average T concentration over the daytime dosing interval following the AM dose; Cmax-PM, time-weighted average concentration over the daytime dosing interval following the PM dose; PK, pharmacokinetic; PM, evening; SD, standard deviation; Tmax-AM/Tmax-PM, Time to Cmax-AM/Cmax-PM; TU, testosterone undecanoate.
aCavg24 calculated using actual sample collection times.
bTmax values are median (range) after AM oral TU dose; TmaxPM values are median (range) after AM oral dose. Mean (range): 12 h = Tmax relative to PM oral TU dose.
cTopical Tmax is relative to the AM dose since it was applied once daily each morning.
dMeasured in NaF-EDTA plasma. Approximate serum T value = 489 ± 155 ng/dL.