Extemporaneous Capsule Product 1 Parameter Test Formulation A Reference Formulation C Ratio % 90 % CI Schuirmann bilateral test (p<80; p>120) Tmax (h) 6.58 8.25         (3.41) (8.02)       Cmax (μg/ml) 3.32 3.14 (1.48) 111.81 73.16 - 170.87 (0.0838 - 0.3701)   (0.84)         AUC0-t 116.34 123.18 92.71 80.16 - 107.22 (0.0483- 0.0096) (μg·h/ml) (33.62) (27.74)       AUC0-∞ 166.96 185.44 89.42 84.01 - 95.17 (0.0095- 0.0002) (μg·h/ml) (38.46) (33.79)       T1/2(h) 38.64 45.04         (8.09) (8.41)       Extemporaneous Capsule Product 2 Parameter Test Formulation B Reference Formulation C Ratio % 90 % CI Schuirmann bilateral test (p<80 p>120); Tmax (h) 4.83 10.00         (3.92) (7.04)       Cmax (μg/ml) 3.10 2.85 107.99 86.25 - 135.22 (0.0233 - 0.1870)   (0.76) (0.59)       AUC0-t 145.66 138.37 104.34 95.58 - 113.89 (0.0014-0.0136) (μg·h/ml) (30.03) (20.95)       AUC0-∞ 244.93 271.65 93.10 76.84 - 112.80 (0.0836 - 0.0239) (μg·h/ml) (65.82) (104.99)       T1/2(h) 55.84 61.29         (21.69) (22.85)       Cmax: peak plasma level; Tmax: time to peak; AUC0-last area under the concentration-time curve from time zero to last point of sampling; AUC0-∞: area under the concentrationtime curve from time zero to infinity; T1/2: Half-life. Formulation A: A-Formula®; Formulation B:Formule®; Formulation C:Tegretol®

Table 2: Pharmacokinetic parameters of carbamazepine in healthy volunteers receiving a 200 mg single dose of the test extemporaneous capsules A-Formula®, Formule®, or the reference tablet Tegretol®. Data is shown as mean (S.D.).

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