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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT03382756
Brief Summary:
A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the bioavailability of CKD-337 after a single oral dose in healthy male subjects
Detailed Description:
This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.
Sixteen male subjects are divided into two groups. A group of subjects are administered a single oral dose of CKD-337 after ingesting high fat meal and the other take same investigational product (IP) in fasting condition. Then their blood is drawn on a fixed schedule to analyse bioavailability of CKD-337.
Finishing the first treatment period, the two groups switch food conditions and initiate the second period. The group of people that were administered CKD-337 with food are then dosed the same IP in fasting condition, and the other group undergo vice versa.
Each treatment period was separated by a washout period of at least 7 days.
Study:
NCT03382756
Study Brief:
Protocol Section:
NCT03382756