NDA-I1: NDA Approval Letter

CLINICAL PHARMACOLOGY Absorption After oral administration, tinidazole is rapidly and completely absorbed. A bioavailability study of Tindamax tablets was conducted in adult healthy volunteers. All subjects received a single oral dose of 2 g (four 500 mg tablets) of tinidazole following an overnight fast. Oral administration of four 500 mg tablets of Tindamax under fasted conditions produced a mean peak plasma concentration (Cmax) of 47.7 (±7.5) μg/mL with a mean time to peak concentration (Tmax) of 1.6 (±0.7) hours and a mean area under the plasma concentration-time curve (AUC, 0-∞) of 901.6 (± 126.5) μg•hr/mL at 72 hours. The elimination half-life (T1/2) was 13.2 (±1.4) hours. Mean plasma levels decreased to 14.3 μg/mL at 24 hours, 3.8 μg/mL at 48 hours and 0.8 μg/mL at 72 hours following administration. Steady-state conditions are reached in 21⁄2 3 days of multi-day dosing. Administration of Tindamax tablets with food resulted in a delay in Tmax of approximately 2 hours and a decline in Cmax of approximately 10%, compared to fasted conditions. However, administration of Tindamax with food did not affect AUC or T1/2 in this study.