A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects
NCT ID: NCT03211143
Last Updated: 2017-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2017-06-20
2017-08-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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A
TR group
Period 1: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days
Period 2: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days
CKD-381
Test drug: CKD-381
Nexium
Reference drug: Nexium
B
RT group
Period 1: Reference drug(Nexium), 1 tablet administered before the breakfast during 7 days
Period 2: Test drug(CKD-381), 1 tablet administered before the breakfast during 7 days
CKD-381
Test drug: CKD-381
Nexium
Reference drug: Nexium
Interventions
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CKD-381
Test drug: CKD-381
Nexium
Reference drug: Nexium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body weight more than 55kg in male, 50kg in female
3. Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
4. If female, must include more than one among the items
* The menopause(there is no natural menses for at least 2 years)
* Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition
5. If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
6. Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent.
Exclusion Criteria
2. Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
4. Have a history of fructose intolerance, glucose-galactose malabsorbtion or sucrase isomaltase deficiency
5. Defined by the following laboratory parameters
* Na\>1.5 upper limit of normal range
* AST, ALT\>1.25 upper limit of normal range
* Total bilirubin\>1.5 upper limit of normal range
* CPK\>1.5 upper limit of normal range
* eGFR(using by MDRD method)\<60mL/min/1.73m2
* Positive for HBV, HCV and HIV by serology test
* Positive by urine drug abuse test.
* Sitting SBP \> 140mmHg or \< 90mmHg, sitting DBP \> 90mmHg or \< 60mmHg, after 5 minutes break.
6. Have a history of drug abuse
7. Subject takes ethical drug or herbal medicine within 14 days, OTC within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects.
8. Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
9. smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
10. A heavy caffeine consumer(caffeine\>5 cups/day), alcohol consumer(alcohol\>210g/week),
11. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
12. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
13. Previously donate whole blood within 60 days or component blood within 30 days.
14. Pregnant or lactating women.
15. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason
19 Years
50 Years
ALL
Yes
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Choon Ok Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Trials center, Yonsei Univ. Health system
Locations
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Severance Hospital
Seoul, , South Korea
Countries
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References
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Kim D, Park MS, Yoo BW, Hong T, Park SJ, Kim CO. The safety, pharmacodynamics, and pharmacokinetics of immediate-release formulation containing esomeprazole 20 mg/sodium bicarbonate 800 mg in healthy adult male. Drug Des Devel Ther. 2019 Sep 3;13:3151-3159. doi: 10.2147/DDDT.S212491. eCollection 2019.
Other Identifiers
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173HPS16024
Identifier Type: -
Identifier Source: org_study_id