A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects

January 7, 2021 updated by: Chong Kun Dang Pharmaceutical

A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Compare Pharmaciokinetics, Pharmacodynamics and Safetry After Single/ Multiple Administration of CKD-382 and D026 in Healthy Subjects

To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects

Study Overview

Detailed Description

A randomized, open-label, crossover phase 1 clinical trial to compare pharmacokinetics, pharmacodynamics and safety after single / multiple administration of CKD-382 and D026 in healthy subjects

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of
        • Recruiting
        • Chungbuk National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 50kg
  3. Body Mass Index more than 18.0 and under 27.0
  4. Who has 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 drug absorption
  3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Period 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
EXPERIMENTAL: B
Period 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
EXPERIMENTAL: C
Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
EXPERIMENTAL: D
Period 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
EXPERIMENTAL: E
Period 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
EXPERIMENTAL: F
Period 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days
1 tablet administered under fasting condition for 7days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose
Time Frame: 0~24h
0~24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor
Time Frame: Baseline versus Multiple dose during 7 days
Baseline versus Multiple dose during 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 25, 2020

Primary Completion (ANTICIPATED)

September 1, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

January 7, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (ACTUAL)

January 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A105_01BE2010

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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