Table II.
Important PK Results % CV in Parenthesis (All Absorption Data Calculated with Gastro Plus)
| PK parameter | Mean | Mean |
|---|---|---|
| Dosage form | IntelliCap® | Mylan ER |
| Dose (mg; diltiazem HCl) | 64.8 | 60.0 |
| Cmax (ng/ml) | 34.7 (28.8) | 39.5 (33.9) |
| AUClast (ng × h/ml) | 494.0 (63.4) | 428.0 (39.1) |
| Tmax (h) | 6.3 (37.1) | 8.0 (24.0) |
| Tlag (h) | 0.5 | 0.7 |
| T½ (h) | 6.6 (22.3) | 6.1 (20.0) |
| Volume of distribution/F (L) | 1,600 (59.5) | 1,420 (47.8) |
| Total clearance/F (L/h) | 177 (65.1) | 163 (47.1) |
| Absorption small intestine (%) | 10.6 | 12.7 |
| Absorption colon (%) | 81.8 | 65.6 |
| Total absorption (%) | 92.4 | 78.3 |
| Literature colonic absorption (%) (7) | 82 |