Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT04494269
Brief Summary:
The main purpose of this study is to compare the pharmacokinetic and safety of tegoprazan following single oral dose in subjects with hepatic impairment versus healthy control.
Detailed Description:
\[Pharmacokinetic Assessment\]
* Measurements
\- Tegoprazan and desmethyl tegoprazan (M1) in blood and urine
* Endpoints
* Primary endpoints: AUClast and Cmax of tegoprazan and M1
* Secondary endpoints: CL/F, t1/2, AUCinf, and fu of tegoprazan; CLrenal and Ae of tegoprazan and M1
\[Safety Assessment\]
* Adverse events (AEs)
* Clinical laboratory tests
* Vital sign
* Physical examination
* Electrocardiogram (ECG)
Study:
NCT04494269
Study Brief:
Protocol Section:
NCT04494269