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Table 2 Summary of pharmacokinetic parameters for surotomycin. Following administration of a single dose and following administration of a single dose (day 1) and multiple doses (day 14)

From: Pharmacokinetics of surotomycin from phase 1 single and multiple ascending dose studies in healthy volunteers

  Single ascending dose Multiple ascending dose
Day 1 Day 14
Parameter 500 mg 1000 mg 2000 mg 4000 mg 250 mg BID 500 mg BID 1000 mg BID 250 mg BID 500 mg BID 1000 mg BID
Tmax, h (range) 6.0 (4.0–8.0) 10.0 (6.00–24.0) 8.0 (4.00–12.0) 12.0 (4.00–12.0) 9.0 (6.0–12.0) 6.0 (6.0–9.0) 7.5 (6.0–9.0) 4.5 (0.0–12.0) 6.0 (0.0–9.0) 1.8 (0.0–6.0)
Cmax, ng/mL (range) 10.5 (5.1–30.1) 21.5 (14.0–56.6) 66.6 (36.9–137) 86.7 (36.1–320) 6.8 (3.4–13.8) 11.0 (6.2–23.1) 21.0 (15.2–27.3) 25.5 (18.3–59.4) 37.6 (16.5–106) 93.5 (67.4–127)
AUC0–t, ng*h/mL (range) 260 (116–531) 664 (499–1648) 1863 (862–3284) 2481 (1419–6521) 41.2 (28.2–101.2) 49.4 (35.0–159) 118 (75.1–157) 274 (203–653) 313 (141–913) 771 (543–1029)
Half-life, h (range) 18.3 (15.5–22.8) 21.1 (14.7–32.5) 16.3 (11.4–34.5) 14.8 (10.4–21.5) ND ND ND ND ND ND
AUC0-∞, ng*h/mL (range) 317 (147–565) 702 (571–1754) 2085 (905–3355) 2572 (1507–6624) ND ND ND ND ND ND
  1. AUC Area under the concentration-time curve, AUC 0-t , AUC from 0 to last measurable plasma concentration; AUC 0-∞ , AUC from 0 to infinity; BID Twice daily, C max Maximum plasma concentration, ND Not determined, T max Time to maximum plasma concentration
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BMC Pharmacology and Toxicology

ISSN: 2050-6511

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