Table 2.
Mean (CV%) pharmacokinetic parameters after subcutaneous administration of 2.92 mg r-hGH/subject by cool.click™ 2 or needle injection
| cool.click™ 2 (test) mean (CV%) | Needle and syringe (reference) mean (CV%) | Ratio (test/ref) | 90% CI for ratio | Falls within 80–125% range? | p-value | |
| AUC0-last (hours·ng/mL) | 125.1 (30) | 119.3 (27) | 104.8 | 98.1, 112.0 | Yes | |
| AUC0-inf (hours·ng/mL) | 135.5 (27) | 131.1 (24) | 103.4 | 97.1, 110.0 | Yes | |
| Cmax (ng/mL) | 20.0 (43) | 18.0 (37) | 110.8 | 103.7, 118.3 | Yes | |
| tmax (hours)* | 3.0 (2–6) | 4.5 (2–6) | 0.002 | |||
| t1/2 (hours) | 2.17 (42) | 2.26 (37) |
CV, coefficient of variation; AUC0-last, area under the serum concentration-time profile from time zero to the last quantifiable concentration; AUC0-inf, area under the serum concentration-time profile from time zero to infinity; Cmax, maximum serum concentration; tmax, time that Cmax occurs; t1/2, elimination half-life. Means are geometric least square means, n = 38
* Median (range)