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

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

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: CKD-381

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: fasted condition/ Period 2: fed condition	Drug: CKD-381; single-dose, oral administration of CKD-381 1 tablet
Experimental: Sequence 2; Period 1: fed condition/ Period 2: fasted condition	Drug: CKD-381; single-dose, oral administration of CKD-381 1 tablet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Kyungsang Yu, M.D., Ph.D., ksyu@snu.ac.kr

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): June 17, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 18, 2021
• Last Update Submitted That Met QC Criteria: August 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: CKD-381
• Other Study ID Numbers: A73_04FDI2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No