Clinical Trials Logo

Clinical Trial Summary

This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug.


Clinical Trial Description

This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral 10 mg dose of TPN171H containing approximately 100 microcuries of [14C]-TPN171H. Subjects will be checked in to the research unit from approximately 24 hours prior to dosing and remain in house until greater than 80% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta in two consecutive time intervals, and blood sample radioactivity concentration at two consecutive time points less than 3 times the plasma background value. This study will investigate the main biotransformation and elimination pathways of TPN171H in the human body and will seek to identify compound's major metabolites. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04655872
Study type Interventional
Source Vigonvita Life Sciences
Contact
Status Completed
Phase Phase 1
Start date November 26, 2020
Completion date January 27, 2021

See also
  Status Clinical Trial Phase
Completed NCT05621447 - A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects Phase 1
Completed NCT02901366 - Mass Balance Study of FYU-981 Phase 2
Not yet recruiting NCT01928563 - Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Udenafil and Dapoxetine Phase 1
Completed NCT05559554 - A Study to Evaluate the PK Similarity of AK104 in Healthy Chinese Male Subjects Phase 1
Completed NCT04512872 - A Phase I Study to Evaluate the Safety and Pharmacokinetics of CT-P41 and EU-approved Prolia in Healthy Male Subjects Phase 1
Active, not recruiting NCT06111196 - Compare the Pharmacokinetics and Safety of BAT3306 Injection Versus KEYTRUDA® Administered in Healthy Male Subjects Phase 1
Completed NCT03317652 - Effect of Sodium Nitroprusside on Cerebral Blood Flow N/A
Active, not recruiting NCT02609711 - Investigate a Interaction of Candesartan and Atorvastatin in Healthy Male Sugjects Phase 1
Withdrawn NCT02560363 - A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects Phase 1
Completed NCT01261260 - Effect of Uridine on GABA and High Energy Phosphate Levels in Healthy Volunteers Phase 1
Completed NCT05072028 - Mass Balance and Biotransformation Study of [14C]DBPR108 in Human Phase 1
Completed NCT05446233 - ADME Study of [14C] Antaitavir Hasophate in Healthy Male Subjects Phase 1
Completed NCT05275010 - A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System Phase 1
Completed NCT04839744 - A Comparative Study of TG103 Produced by Two Manufacturing Processes in Chinese Healthy Male Subjects Phase 1
Completed NCT05792917 - Bioequivalence Study of Tafolecimab Injections in Chinese Healthy Male Volunteers Phase 1
Completed NCT03576651 - A Study to Compare the Pharmacokinetics of JHL1149 and Bevacizumab (Avastin) in Healthy Male Volunteers Phase 1
Completed NCT04825431 - Mass Balance Study of [14C] TAS-205 in Healthy Volunteers Phase 1
Completed NCT01819779 - Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60) Phase 1
Completed NCT05126784 - AVT03 With Prolia in Healthy Male Subjects Phase 1
Completed NCT04850638 - Drug Interaction Between SHR4640 Tablets and Furosemide Tablets in Healthy Volunteers (Single Center, Single Arm, Open, Self-control) Phase 1