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Randomized Controlled Trial
. 2020 Apr 21;64(5):e02067-19.
doi: 10.1128/AAC.02067-19. Print 2020 Apr 21.

Effects of Tenofovir on the Single-Dose Pharmacokinetics of Intravenous Morinidazole in Healthy Chinese Subjects

Guolan Wu  1   2 , Wenling Tang  3 , Duo Lv  1   2 , Lihua Wu  1   2 , Huili Zhou  1   2 , Xi Yang  4 , Yunliang Zheng  1   2 , You Zhai  1   2 , Jianzhong Shentu  5   2
Affiliations
Randomized Controlled Trial

Effects of Tenofovir on the Single-Dose Pharmacokinetics of Intravenous Morinidazole in Healthy Chinese Subjects

Guolan Wu et al. Antimicrob Agents Chemother. .

Abstract

The effects of multiple-dose administration of tenofovir disoproxil fumarate (TDF) on the pharmacokinetics of morinidazole (MOR) were compared in healthy subjects. MOR exposure was similar, with an area under the curve from 0 h to infinity (AUC0-∞) treatment ratio for MOR+TDF/MOR of 1.01 (90% confidence interval, 0.97 to 1.06). No relevant differences were observed regarding plasma exposure of metabolites. Renal clearances of MOR and its metabolites were not affected by TDF. No unexpected safety or tolerability issues were observed.

Keywords: clinical pharmacokinetics; drug-drug interaction; morinidazole; organic anion transporter; tenofovir.

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Figures

FIG 1
FIG 1
Study design.
FIG 2
FIG 2
Mean plasma concentration-time profiles of morinidazole (MOR) (A), M2 (B), M7 (C), M8-1 (D), and M8-2 (E) after intravenous infusion of morinidazole 500 mg in healthy Chinese subjects with or without pretreatment with TDF. Data expressed as means ± standard deviation (n = 15). M0, morinidazole.
FIG 3
FIG 3
Urinary excretion of morinidazole (MOR) and its major metabolites after intravenous infusion of morinidazole 500 mg, with or without pretreatment with TDF, in healthy Chinese subjects. Data expressed as means ± standard deviation (n = 15). Ae, amount of drug excreted; M0, morinidazole.
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