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NCT04830930 Clinical Trial

A Study to Investigate the Effect of Food on the PK, PD of CKD-381 in Healthy Volunteers

GERD Clinical Trial

Official title:
A Randomized, Open-label, Single-dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of CKD-381 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04830930
Other study ID # A73_04FDI2102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 21, 2021
Est. completion date July 26, 2021

Study information
Verified date March 2021
Source Chong Kun Dang Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A study to investigate the effect of food on the Pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Description:

A randomized, open-label, single-dose, crossover study to investigate the effect of food on the pharmacokinetics and pharmacodynamics of CKD-381 in healthy volunteers

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date July 26, 2021
Est. primary completion date June 17, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 50 Years
Eligibility Inclusion Criteria: 1. Between 19 aged and 50 aged in healthy adult 2. Body weight more than 55.0kg and body mass index over 18.0kg/m2 and under 30.0kg/m2 3. Have negative result on Helicobacter Pylori antibody test Exclusion Criteria: 1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease. 2. Have a gastrointestinal disease history(including surgery) that can effect evaluation of safety, pharmacokinetics and pharmacodynamics of investigational product. 3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of investigational product, additives or benzimidazole family.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CKD-381
single-dose, oral administration of CKD-381 1 tablet

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cmax maximum observed concentration after dose 0-24 hours
Primary AUClast Area under the plasma concentration versus time curve over the dosing interval after dose 0-24 hours
Primary Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose 0-24 hours
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