A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects
Phase 1
Completed
- Conditions
- GERD
- Interventions
- Drug: D026Drug: CKD-381
- Registration Number
- NCT03558425
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 41
Inclusion Criteria
- Between 19 aged and 50 aged in healthy male adult
- Body weight more than 55kg
- Body Mass Index more than 18.5 and under 25
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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 that can effect drug absorption or surgery.
- Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description TR group D026 Period 1: Test drug(CKD-381) Period 2: Reference drug(D026) RT group CKD-381 Period 1: Reference drug(D026) Period 2: Test drug(CKD-381)
- Primary Outcome Measures
Name Time Method AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state) 0~24h Evaluation PK for Esomeprazole after multiple dose
Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose Baseline versus Multiple dose during 7 days Evaluation PD for ambulatory 24hr pH monitor
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul Nat'l University Hospital
🇰🇷Seoul, Korea, Republic of