Clinical trial NCT05108038: A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects
Official title: A Randomized, Open-label, Crossover Phase 1 Clinical Trial to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety After Single/Multiple Administration of CKD-382, D860 and D027 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: GERD
Keywords: CKD-382
D860
D027
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 42
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Detailed description: A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Eligibility criteria: Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* Body weight more than 50kg
* BMI 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 of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family

Primary outcomes:
measure: Primary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: Primary Pharmacodynamic Endpoint
timeFrame: 24 hours after multiple dose for 7 days compared to baseline
Secondary outcomes:
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (2) Secondary Pharmacokinetic Endpoint
timeFrame: 0 hour(pre dose), 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24 hours
measure: (1) Secondary Pharmacodynamic Endpoint
timeFrame: 24 hours after first dose compared to baseline
measure: (2) Secondary Pharmacodynamic Endpoint
timeFrame: 24 hours after first dose and multiple dose for 7 days
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk Ntional University Hospital
Study officials:
References: