Table 2: Pharmacokinetic Parameters Following Single Dose Administration of SOLOSEC 2 g Given Orally 

    Cmax (mcg/mL)

 

    Tmax (hr)*

 

    AUC (mcg•hr/mL)

 

* Median (range) † Admixed with applesauce  

 

    Fasted† (N=23)

    Mean (SD)     41.2 (5.5)     4.0 (3.0 - 6.0)     1261.5 (236.5) 

     Range     32.7 – 56.2      874.3 – 1750.4 

 

    High fat meal† (N=23)

    Mean (SD)     40.1 (4.9)     6.0 (4.0 - 8.0)     1248.2 (291.6) 

     Range     31.0 – 47.7      762.0 – 1769.4 

 

    Mixed with applesauce (N=24)

    Mean (SD)     44.1 (4.6)     4.0 (3.0 – 6.1)     1523 (372.2) 

     Range     37.4 – 55.6      1040 - 2350 

 

    Mixed with pudding (N=23)

    Mean (SD)     45.6 (5.1)     4.0 (4.0 – 6.0)     1447 (331.0) 

     Range     38.6 – 60.4      997 - 2130 

 

    Mixed with yogurt (N=24)

    Mean (SD)     43.4 (5.4)     4.0 (4.0 – 8.0)     1478 (335.0) 

     Range     36.3 – 59.3      965 - 2240 

Distribution 

 

The apparent volume of distribution of secnidazole is approximately 42 L. The plasma protein binding of secnidazole is <5%.

 

Elimination 

 

The total body clearance of secnidazole is approximately 25 mL/min. The renal clearance of secnidazole is approximately 3.9 mL/min.

 

The plasma elimination half-life for secnidazole is approximately 17 hours.

 

Metabolism 

 

Secnidazole is metabolized in vitro via oxidation by human hepatic CYP450 enzyme system with ≤ 1% conversion to metabolites.

 

Excretion 

 

Approximately 15% of a 2 g oral dose of SOLOSEC is excreted as unchanged secnidazole in the urine.

 

Drug Interactions 

 

Oral Contraceptives