. 2021 Aug 11;185(5):607–615. doi: 10.1530/EJE-21-0606
This work is licensed under a Table 4.
Pharmacokinetic summary of data comparing native testosterone (NT) with testosterone undecanoate (TU) and NT taken fasted and fed in hypogonadal men (baseline-adjusted pharmacokinetic set). Data are presented as mean (s.d.).
| Cohort 1† | Cohort 2‡ | |||||
|---|---|---|---|---|---|---|
| DITEST 120 mg | TU 80 mg | GLSM ratio (90% CI) | Fed | Fasted | GLSM ratio (90% CI) | |
| Testosterone | ||||||
| Cmax | ||||||
| ng/dL | 554 (481) | 911 (670) | 55.6 (45–68.7) | 769 (421) | 882 (458) | 85.1 (57.5–126.0) |
| nmol/L | 19.1 (16.6) | 31.4 (23.1) | 26.5 (14.5) | 30.4 (15.8) | ||
| AUC0–10 h | ||||||
| h ng/dL | 1726 (1578) | 2958 (2480) | 51.3 (34.7–75.7) | 2523 (1615) | 2569 (1496) | 94.2 (66.1–134.2) |
| h nmol/L | 59.5 (54.4) | 102 (85.5) | 87.0 (55.7) | 88.6 (51.6) | ||
| Tmax h | 1.4 (1.0) | 4.2 (2.1) | 1.4 (0.6) | 1.2 (0.6) | ||
| TU | ||||||
| Cmax | ||||||
| ng/dL | 20 900 (8500) | |||||
| nmol/L | 458 (186) | |||||
| AUC0–10 h | ||||||
| h ng/dL | 47 200 (18500) | |||||
| h nmol/L | 1034 (405) | |||||
| Tmax h | ||||||
| DHT | 3.8 (2.3) | |||||
| Cmax | ||||||
| ng/dL | 84 (99) | 194 (119) | 119 (58) | 131 (61) | ||
| nmol/L | 2.9 (3.4) | 6.7 (4.1) | 4.1 (2.0) | 4.5 (2.1) | ||
| AUC0–10 h | ||||||
| h ng/dL | 319 (351) | 1053 (850) | 467 (270) | 484 (299) | ||
| h nmol/L | 11.0 (12.1) | 36.3 (29.3) | 16.1 (9.3) | 16.7 (10.3) | ||
| Tmax h | 2.4 (2.1) | 5.7 (1.9) | 1.7 (0.6) | 1.6 (0.7) | ||
To convert testosterone nmol/L to ng/dL multiply by 29; To convert DHT nmol/L to ng/dL multiply by 29; To convert TU ug/L to ng/dL multiply by 100; To convert TU multiply ug/L by 2.19 to get nmol/L. †Fed NT 120 mg vs TU 80 mg. ‡NT 200 mg fed vs fasted.
GLSM, geometric least squared mean.