- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04703374
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
Status
Unknown
Conditions
Intervention / Treatment
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:
- Between 19 aged and 50 aged in healthy adult
- Body weight more than 50kg
- Body Mass Index more than 18.0 and under 27.0
- Who has negative result on Helicobacter Pylori antibody test
Exclusion Criteria:
- 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.
- Have a gastrointestinal disease history(including surgery) that can effect drug absorption
- 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.
Sponsor
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
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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