Table III.
PK parameters | Promptol™ tablet (10 mg, test) | Inderal® tablet (10 mg, reference) | p value |
---|---|---|---|
T max (min) | 102 ± 67 | 107 ± 33 | 0.772 |
C max (ng/ml) | 15.5 ± 5.6 | 8.6 ± 5.8 | 0.000 |
AUC0–last (μg min/ml) | 4.60 ± 1.66 | 1.95 ± 1.40 | 0.000 |
AUC0–∞ (μg min/ml) | 5.36 ± 2.04 | 2.26 ± 1.65 | 0.000 |
T 1/2 (min) | 184 ± 38 | 171 ± 55 | 0.336 |
Relative F (%) | 300 ± 127 | N/A | N/A |
T max time to peak drug concentration, C max peak drug concentration, AUC 0–last area under the concentration–time curve from time zero to the last sampling time t obtained by trapezoidal rule, AUC 0–∞ area under the concentration–time curve from time zero to infinity, T 1/2 terminal elimination half-life, F relative bioavailability for the sublingual Promptol™ tablet to oral Inderal® tablet, N/A not applicable