Table 2. Summary table of pharmacokinetic parameters of tegoprazan and M1 following multiple administration.
| Parameter | Co-administration* (n = 23) | Alone† (n = 23) | GMR (90% CI) | |
|---|---|---|---|---|
| Tegoprazan | ||||
| Css,max (µg/L) | 3,095.95 ± 812.65 | 1,868.63 ± 409.68 | 1.6474 (1.5062–1.8019) | |
| AUCss,tau (µg∙hr/L) | 27,796.43 ± 10,513.59 | 10,817.59 ± 2,783.29 | 2.4986 (2.3525–2.6538) | |
| Tmax (hr)‡ | 1.5 (1.00–4.00) | 1.00 (0.50–4.00) | - | |
| t1/2 (hr) | 7.97 ± 2.24 | 4.89 ± 1.02 | - | |
| M1 | ||||
| Css,max (µg/L) | 2,249.80 ± 1,027.45 | 1,085.28 ± 360.34 | 2.0044 (1.8274–2.1987) | |
| AUCss,tau (µg∙hr/L) | 38,714.57 ± 18,127.33 | 14,726.31 ± 4,285.58 | 2.5016 (2.3145–2.7038) | |
| Tmax (hr)‡ | 4.00 (2.00–24.00) | 4.00 (1.00–4.00) | ||
| t1/2 (hr) | 128.83 ± 106.62 | 22.27 ± 9.99 | ||
| Metabolic ratio§ | 1.55 ± 0.61 | 1.48 ± 0.45 | ||
Data were shown as arithmetic mean ± standard deviation and geometric mean (90% confidence interval).
GMR, geometric ratio; CI, confidential interval; Css, max, maximum plasma concentration at steady state; AUCss,tau, area under the plasma concentration-time curves during dosing interval at steady state; tss, max, time to reach Css, max; t1/2, apparent terminal elimination half-life.
*Tegoprazan 200 mg once daily and clarithromycin 500 mg twice daily for 5 days; †Tegoprazan 200 mg once daily for 5 days; ‡Median (minimum - maximum); §Metabolic ratio was calculated as AUCM1 divided by AUCtegoprazan.