TABLE 3.
Comparison between experimental rat C max and human C max to assess clinical relevance of findings in rats
| Drug/dose administered to rats | Mean rat C max (ng/ml) | Drug and dosage administered to human | Mean human C max (ng/ml) | Potential clinical relevance category |
|---|---|---|---|---|
| Oxycodone 150 mg/kg | 51.5 | Oxycodone 40 mg extended‐release tablet (single dose) | 48 47 | A |
| Clozapine 25 mg/kg | 65.3 | Clozapine 100 mg tablet nightly (steady‐state) | 275 48 | D |
| Cyclobenzaprine 30 mg/kg | 6.4 | Cyclobenzaprine 15 mg extended‐release capsule (single dose) | 8.3 49 | A |
| Duloxetine 50 mg/kg | 465.1 | Duloxetine 60 mg capsule Q12H (steady‐state) | 128.5 50 | C |
| Mirtazapine 50 mg/kg | 87.5 | Mirtazapine 30 mg tablet nightly (steady‐state) | 69.7 51 | B |
| Paroxetine 5 mg/kg | 54.9 | Paroxetine HCl 30 mg tablet daily (steady‐state) | 61.7 52 | B |
| Paroxetine 50 mg/kg | 1090.0 | Paroxetine HCl 30 mg tablet daily (steady‐state) | 61.7 53 | C |
| Quetiapine 25 mg/kg | 46.3 | Quetiapine 25 mg tablet (single dose) | 79 54 | A |
| Quetiapine 250 mg/kg | 512.3 | Quetiapine 150 mg tablet twice daily (steady‐state) | 445.7 55 | B |
| Ramelteon 30 mg/kg | 768.2 | Ramelteon 8 mg tablet (single dose) | 5.73 56 | C |
| Risperidone 10 mg/kg | 108.5 | Risperidone 8 mg tablet daily (steady‐state) | 155 57 | B |
| Suvorexant 60 mg/kg | 1668.0 | Suvorexant 20 mg tablet nightly (steady‐state) | 258.8 58 | C |
| Topiramate 20 mg/kg | 8830.3 | Topiramate 100 mg tablet Q12H (steady‐state) | 8400 59 | B |
| Trazodone 100 mg/kg | 991.1 | Trazodone 50 mg tablet (single dose) | 755 60 | A |
| Trazodone 100 mg/kg | 991.1 | Trazodone 300 mg extended‐release tablet daily (steady‐state) | 1812 61 | D |
| Zolpidem 50 mg/kg | 1243.4 | Zolpidem 10 mg tablet (single dose) | 111.6 62 | C |
| Carisoprodol 50 mg/kg | 115.3 | Carisoprodol 250 mg tablet (single dose) | 1200 63 | D |
Abbreviation: Cmax, maximum plasma concentration.