Table 4.

Summary statistics of bioequivalence study data after single dose subcutaneous injection of test and branded formulations of dalteparin (n = 83*).

Parametera	Geometric least square means
	Test (T)	Branded (R)	% (T/R) ratio	90% CI	% power
Anti-Xa activity
Amax (IU/mL)	1.31	1.36	96.6	93.35–99.95	100.0
AUC0–t (IU•h/mL)	11	11.7	93.6	90.59–96.77	100.0
AUC0–∞ (IU•h/mL)	12.5	13.7	91.2	86.26–96.45	99.9
Anti-IIa activity
Amax (IU/mL)	0.32	0.32	99.9	94.68–105.45	99.9
AUC0–t (IU•h/mL)	1.94	1.99	97.3	92.53–102.41	99.9
AUC0–∞ (IU•h/mL)	2.36	2.48	94.9	90.31–99.79	99.9
Heptest
Amax (IU/mL)	0.82	0.83	99.2	96.86–101.55	100.0
AUC0–t (IU•h/mL)	6.63	6.92	95.9	94.28–97.51	100.0
AUC0–∞ (IU•h/mL)	7.24	7.56	95.8	94.32–97.31	100.0
aPTT
(Δt)max (s)	6.81	6.63	103	98.57–106.64	100.0
AU(Δt) (s.h)	43.7	43.6	100	92.46–108.06	99.9
AUC0–∞ (anti-Xa)/AUC0–∞ (anti-IIa) ratio
AUC0–∞ (anti-Xa)/AUC0–∞ (anti-IIa)	5.31	5.53	96.1	89.48–103.19

^aNature log-transformed.

*n = 83; Subjects 41, 44, 52, 57, and 68 had not completed both periods of the study and, hence, were excluded from pharmacokinetic and statistical analysis.