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No. | Author | Year | Race | Mirogabalin | Concomitant medicine | PK parameter of mirogabalin | Safety assessment | Conclusion |
Dose | Drug | Dose |
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1 | James Dow et al. | 2018 | Unknown | 15 mg | Metformin | 850 mg | PK parameters were similar when administered alone or in combination | Dyspepsia, encephalalgia, increased hepatic enzymes (AST and ALT were 2.7 and , respectively). | Well tolerated with no evidence of a drug-drug interaction. |
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2 | Mendel Jansen et al. | 2018 | Unknown | 20 mg | Lorazepam | 2 mg | PK parameters were similar when administered alone or in combination | Increased effects in body sway and DSST assays; increased occurrence of somnolence. | Potentially increased central nervous system-related AEs when lorazepam or ethanol was coadministered with mirogabalin. |
Zolpidem | 10 mg | decreased by 11%, (90% CI), 0.89 (0.82, 0.96) | Increased occurrence of somnolence. |
Tramadol | 100 mg | decreased by 28%, (90% CI), 0.72 (0.67, 0.76) | Increased incidence of nausea. |
Ethanol | 240 mL men/200 mL women | increased by 20%, (90% CI), 1.20 (1.12, 1.28) | Increased the PD effects in body sway and DSST assays; increased incidence of encephalalgia. |
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3 | Masaya Tachibana et al. | 2018 | White, Black, African American | 15 mg | Probenecid | 500 mg Q6H | AUC0-last and increased by 76% and 29% | No clinically significant changes in vital signs or ECGs. | No necessary to dose adjustment with administration of probenecid and cimetidine, since the effect was not significant (>2-fold). |
Cimetidine | 400 mg Q6H | AUC0-last and increased by 44% and 17% |
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