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Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects

Sihuan Pharmaceutical Holdings Group Ltd. · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single oral dose of \[14C\]-20 mg/100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects. Whole blood, plasma samples will be collected at hour 0 pre-dose and 1,2,3,4,5,6,8,12,24,48,72,96,120,144,168 hours post-dose (tentative, adjusted according to plasma drug concentration); urine samples will be collected at hour 24 pre-dose and 0-4,4-8,8-12,12-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate) ; fecal samples will be collected at hour 24 pre-dose and 0-24,24-48,48-72,72-96,96-120,120-144,144-168,168-192,192-216,216-240 hours post-dose (tentative, adjusted according to sample recovery rate) following the start of administration to measure total radioactivity and plasma drug concentrations.
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