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. 2010 Apr 26;54(7):2965–2973. doi: 10.1128/AAC.01198-09

TABLE 4.

GMR of plasma lopinavir and ritonavir pharmacokinetic measurements compared with data for 4 lopinavir-ritonavir capsules BD and 2 lopinavir-ritonavir tablets BD without NNRTIsa

Dose and parameter Dose for comparison Value for group
Lopinavir plus:
 Ritonavir plus:
Efavirenz (n = 20)
 Nevirapine (n = 18)
 Efavirenz (n = 20)
 Nevirapine (n = 18)
GMR (90% CI) P GMR (90% CI) P GMR (90% CI) P GMR (90% CI) P
4 capsules BD
    AUC0-12 (μg/ml) 3 tablets BD 1.40 (1.18, 1.65) 0.002 1.66 (1.46, 1.88) <0.001 1.44 (1.19, 1.75) 0.003 1.88 (1.56, 2.26) <0.001
2 tablets BD 0.82 (0.68, 0.99) 0.09 0.90 (0.77, 1.06) 0.27 0.85 (0.69, 1.04) 0.18 0.93 (0.77, 1.13) 0.54
    Cmax (μg/ml) 3 tablets BD 1.34 (1.16, 1.54) 0.002 1.45 (1.28, 1.66) 0.0001 1.41 (1.14, 1.73) 0.01 1.81 (1.50, 2.19) <0.001
2 tablets BD 0.90 (0.78, 1.05) 0.26 0.92 (0.80, 1.06) 0.31 0.88 (0.72, 1.08) 0.30 0.91 (0.71, 1.15) 0.49
    C12 (μg/ml) 3 tablets BD 1.48 (1.09, 2.02) 0.04 2.31 (1.64, 3.24) 0.0005 1.33 (1.06, 1.67) 0.04 1.59 (1.18, 2.15) 0.01
2 tablets BD 0.62 (0.39, 0.98) 0.08 0.80 (0.57, 1.12) 0.26 0.80 (0.60, 1.06) 0.18 0.78 (0.61, 1.00) 0.10
    t1/2 (h) 3 tablets BD 1.14 (0.92, 1.41) 0.31 1.05 (0.74, 1.49) 0.81 0.88 (0.73, 1.06) 0.24 0.71 (0.60, 0.83) 0.002
2 tablets BD 0.87 (0.67, 1.13) 0.36 0.63 (0.47, 0.84) 0.01 0.89 (0.74, 1.08) 0.32 0.71 (0.60, 0.85) 0.004
2 tablets BD with no NNRTI
    AUC0-12 (μg/ml) 3 tablets BD 0.83 (0.66, 1.05) 0.21 1.03 (0.87, 1.21) 0.81 1.12 (0.86, 1.47) 0.48 1.33 (1.06, 1.66) 0.05
2 tablets BD 0.49 (0.38, 0.63) <0.001 0.56 (0.45, 0.70) <0.001 0.66 (0.51, 0.86) 0.01 0.66 (0.51, 0.85) 0.01
    Cmax (μg/ml) 3 tablets BD 0.91 (0.75, 1.11) 0.45 1.00 (0.87, 1.15) 0.98 1.15 (0.89, 1.47) 0.37 1.40 (1.11, 1.77) 0.02
2 tablets BD 0.62 (0.51, 0.74) <0.001 0.63 (0.53, 0.76) <0.001 0.72 (0.57, 0.92) 0.03 0.70 (0.54, 0.90) 0.03
    C12 (μg/ml) 3 tablets BD 0.51 (0.31, 0.83) 0.03 0.96 (0.72, 1.27) 0.80 0.87 (0.60, 1.25) 0.53 1.03 (0.78, 1.37) 0.85
2 tablets BD 0.21 (0.12, 0.37) <0.001 0.33 (0.22, 0.49) <0.001 0.52 (0.37, 0.73) 0.003 0.51 (0.37, 0.70) 0.001
    t1/2 (h) 3 tablets BD 0.60 (0.43, 0.83) 0.01 0.93 (0.69, 1.26) 0.70 0.80 (0.68, 0.95) 0.04 0.80 (0.68, 0.93) 0.02
2 tablets BD 0.45 (0.33, 0.62) <0.001 0.52 (0.39, 0.69) <0.001 0.82 (0.70, 0.95) 0.04 0.81 (0.70, 0.93) 0.02
a

Note that boldface type indicates parameters meeting the formal definition of bioequivalence (90% CI within the range of 0.8 to 1.25). Comparison to data for 4 capsules BD is a within-person comparison and is powered for bioequivalence. Comparison to data for 2 tablets BD without NNRTIs is a between-person comparison and is not powered for equivalence.