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Mean (CV%) pharmacokinetic parameters after subcutaneous administration of 2.92 mg r-hGH/subject by cool.click™ 2 or needle injection |
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| 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 |
|
|
|
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| 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 |
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| t1/2 (hours) |
2.17 (42) |
2.26 (37) |
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|
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) | ||||||
Brearley et al. BMC Clinical Pharmacology 2007 7:10 doi:10.1186/1472-6904-7-10 |
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