A Study to Compare PK, PD and Safety of CKD-382 in Healthy Subjects
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
1 other identifier
interventional
48
1 country
1
Brief Summary
To compare pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382 and D026 in healthy subjects
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2020
CompletedFirst Submitted
Initial submission to the registry
January 7, 2021
CompletedFirst Posted
Study publicly available on registry
January 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedJanuary 11, 2021
January 1, 2021
11 months
January 7, 2021
January 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) Evaluation PK after multiple dose
0~24h
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Evaluation PD for ambulatory 24hr pH monitor
Baseline versus Multiple dose during 7 days
Study Arms (6)
A
EXPERIMENTALPeriod 1: Test drug(CKD-382 formulation I) Period 2: Test drug(CKD-382 formulation II) Period 3: Reference drug(D026)
B
EXPERIMENTALPeriod 1: Test drug(CKD-382 formulation II) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation I)
C
EXPERIMENTALPeriod 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation I) Period 3: Test drug(CKD-382 formulation II)
D
EXPERIMENTALPeriod 1: Test drug(CKD-382 formulation I) Period 2: Reference drug(D026) Period 3: Test drug(CKD-382 formulation II)
E
EXPERIMENTALPeriod 1: Test drug(CKD-382 formulation II) Period 2: Test drug(CKD-382 formulation I) Period 3: Reference drug(D026)
F
EXPERIMENTALPeriod 1: Reference drug(D026) Period 2: Test drug(CKD-382 formulation II) Period 3: Test drug(CKD-382 formulation I)
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2021
First Posted
January 11, 2021
Study Start
September 25, 2020
Primary Completion
September 1, 2021
Study Completion
September 1, 2021
Last Updated
January 11, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share