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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

Healthy Male Volunteers Clinical Trial

Official title:
A Single-center, Open, Single Dose Mass Balance Study to Assess the Absorption, Metabolism, Excretion of [14C]-20 mg/100 μCi Anaprazole Sodium Enteric-coated Capsule in Chinese Health Adult Male Subjects

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04476394
Study type Interventional
Source Sihuan Pharmaceutical Holdings Group Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date August 3, 2020
Completion date September 30, 2020
View Details
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