Table 3.
Summary of the pharmacokinetic parameters of metformin in healthy volunteers with and without nizatidine co-administration.
| Metformin Alone | Metformin + Nizatidine | p-value | |
|---|---|---|---|
| tmax (hr) | 2.46±0.66 | 2.13±0.38 | 0.09 |
| Cmax (μg/mL) | 1.81±0.60 | 1.68±0.55 | 0.43 |
| AUC0–24 (μg.hr/mL) | 11.0±3.1 | 9.6±2.1 | 0.20 |
| AUCinf (μg.hr/mL) | 11.4±3.3 | 10.0±2.4 | 0.25 |
| V/F (L) | 577±179 | 799±239 | 0.01 |
| CL/F (mL/min) | 1360±440 | 1480±330 | 0.46 |
| t1/2 (hr) | 5.1±1.4 | 6.3±1.6 | 0.05 |
| a Amount in urine0–24 (mg) | 437±86 | 376±128 | 0.10 |
| a CLR (mL/min) | 736±204 | 670±133 | 0.18 |
| CLIHX (mL/min) | 118±19 | 110±13 | 0.09 |
| a CLCR (mL/min) | 156±40 | 147±26 | 0.28 |
| a CLSR (mL/min) | 615±201 | 558±134 | 0.22 |
Due to incomplete urine collection from one subject, the amount in urine, CLR, CLCR, CLSR were calculated from 11 subjects. Data is presented as mean ± SD.
tmax, time to the maximal plasma concentration; Cmax, maximal plasma concentration; AUC0–24, area under the concentration-time curve from 0–24 hr time point; AUCinf, area under the concentration-time curve from 0 to infinity; V/F, apparent volume of distribution; CL/F, apparent oral clearance; t1/2, plasma terminal elimination half-life; CLR, renal clearance; CLIHX, iohexol clearance, CLCR, creatinine clearance; CLSR, net renal clearance by secretion (metformin CLR less CLIHX for each individual subject)