Clinical data used for PBPK model verification
| Drug | Age Range | Number of Subjects | Male/Female Numbers | Dose (Route) | Dosage Regimen/PK Duration | Comments | Reference |
|---|---|---|---|---|---|---|---|
| yr | |||||||
| Benzydamine | 41–51 | 6 | 6/0 | 5 mg (i.v.) | Single/48 hours | Caucasian healthy volunteers | Humphries et al. (2015) |
| Benzydamine | 18–51 | 12 | 6/6 | 50 mg (oral) | Single/48 hours | Caucasian healthy volunteers | Humphries et al. (2015) |
| Itopride | — | 6 | 6/0 | 50 mg (oral) | Single/24 hours | Japanese healthy volunteers | Yoon et al. (2014) |
| Itopride | 24–31 | 5 | 5/0 | 150 mg (oral) | Single/24 hours | Japanese healthy volunteers | Katagiri et al. (2006) |
| Tozasertib | 22–80 | 27 | 14/13 | 4, 8, 16, 32, 45, 64, and 96 mg/m2 (i.v.) | Single, 24-hour infusion | Oncology patients | Traynor et al. (2011) |
| Tamoxifen | 29–71 | 29 | 4/25 | 20 mg (oral) | Multiple, PK at SS | Oncology patients | AstraZeneca internal dataa |
| Tamoxifen | 41–64 | 24 | 0/24 | 30 mg (oral) | Single | Healthy volunteers | Fuchs et al. (1996) |
| Moclobemide | 21–30 | 12 | 12/0 | 150 mg (i.v.), 20 minute infusion | Single | Healthy volunteers | Raaflaub et al. (1984) |
| Moclobemide | 21–30 | 12 | 12/0 | 100 mg (oral) | Single | Healthy volunteers | Schoerlin et al. (1987) |
| Imipramine | 23–64 | 8 | 8/0 | 100 mg (oral) | Single | Caucasian healthy volunteers | Albers et al. (2000) |
| Imipramine | 22–37 | 11 | 5/6 | 50 mg (i.v.) and 100 mg (oral) | Single | Caucasian healthy volunteers | Brøsen and Gram (1988) |
| Clozapine | 21–30 | 18 | 18/0 | 100 mg (oral); twice daily | Single | Asian healthy volunteers | Tassaneeyakul et al. (2005) |
| Clozapine | 30–32 | 2 | 2/0 | 200 and 600 mg (oral) | Multiple, PK at SS | Caucasian schizophrenic patients | Takano et al. (2006) |
| Olanzapine | 28–50 | 10 | 10/0 | 10 mg, oral | Single | Schizophrenic patients | Elshafeey et al. (2009) |
| Olanzapine | 19–41 | 24 | 24/0 | 10 mg (oral) | Single | Healthy volunteers | Chiu et al. (2004) |
| Ranitidine | 21–23 | 6 | 6/0 | 20 mg (i.v.) and 100 mg (oral) | Single | Healthy volunteers | McNeil et al. (1981) |
| Ranitidine | 19–32 | 12 | 12/0 | 100–400 mg (oral) | Single and multiple | Healthy volunteers | Garg et al. (1985) |
SS, steady-state. —, data not available or not reported.
↵a Clinical trial NCT02093351: To assess safety and effect of olaparib on the pharmacokinetics of anastrozole, letrozole, and tamoxifen, and their effect on olaparib, in patients with advanced solid cancer (2017).