Pharmacokinetics, Safety, and Tolerability of Tenapanor in Healthy Chinese and Caucasian Volunteers: A Randomized, Open-Label, Single-Center, Placebo-Controlled Phase 1 Study

Table 3

Linear analysis of pharmacokinetic parameters of different dose groups in Chinese healthy subjects.

T-test of linear regression coefficient
PK parameters	Slope	Statistic (t)		90% CI	95% CI	Judgment interval^a	Judgment interval^b
	0.71	8.00	<0.0001	[0.56, 0.86]	[0.53, 0.89]	[0.86, 1.14]	[0.57, 1.43]
AUC0-t	0.98	8.36	<0.0001	[0.78, 1.18]	[0.74, 1.22]	[0.86, 1.14]	[0.57, 1.43]
AUC0-∞	0.68	6.59	<0.0001	[0.50, 0.85]	[0.47, 0.89]	[0.86, 1.14]	[0.57, 1.43]

Note. The linear pharmacokinetic characteristics of PK parameters were evaluated by power function model. The terminal elimination phase is linear, so AUC_0-∞ with extrapolation area greater than 20% is also included in the model calculation. ^aAdopt Smith standard:  = 0.80 and  = 1.25 [21]. ^bAdopt Hummel standard:  = 0.5 and  = 2.0 [22]. Calculation of judgment interval: [1 + ln()/ln(r), 1 + ln()/ln(r)]. r = maximum dose/minimum dose.