Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04476394
Status:
UNKNOWN
Last Update Posted:
2020-07-20
First Post:
2020-07-15
Brief Title:
Open-label Study to Assess the Absorption Metabolism Excretion and Mass Balance of a Single Oral Dose of 14C-20 mg100 μCi Anaprazole Sodium Enteric-coated Capsule in Healthy Adult Male Subjects
Sponsor:
Sihuan Pharmaceutical Holdings Group Ltd
Organization:
Sihuan Pharmaceutical Holdings Group Ltd
Study Overview
Official Title:
A Single-center Open Single Dose Mass Balance Study to Assess the Absorption Metabolism Excretion of 14C-20 mg100 μCi Anaprazole Sodium Enteric-coated Capsule in Chinese Health Adult Male Subjects
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label single-dose absorption metabolism excretion and mass balance study following a single oral dose of 14C-20 mg100 μCi Anaprazole Sodium enteric-coated capsule in healthy adult male subjects Whole blood plasma samples will be collected at hour 0 pre-dose and 12345681224487296120144168 hours post-dose tentative adjusted according to plasma drug concentration urine samples will be collected at hour 24 pre-dose and 0-44-88-1212-2424-4848-7272-9696-120120-144144-168168-192192-216216-240 hours post-dose tentative adjusted according to sample recovery rate fecal samples will be collected at hour 24 pre-dose and 0-2424-4848-7272-9696-120120-144144-168168-192192-216216-240 hours post-dose tentative adjusted according to sample recovery rate following the start of administration to measure total radioactivity and plasma drug concentrations
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None