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A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT03211143
First received: July 5, 2017
Last updated: NA
Last verified: June 2017
History: No changes posted
  Purpose
A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects

Condition Intervention Phase
GERD Drug: CKD-381 Drug: Nexium Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D027 in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Chong Kun Dang Pharmaceutical:

Primary Outcome Measures:
  • Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ)) [ Time Frame: 0h~12 h ]
    Evaluating PK of Esomeprazole after Multiple dose

  • Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose) [ Time Frame: Baseline versus Multiple dose during 7days ]
    Evaluating PD for ambulatory 24hr pH monitor


Estimated Enrollment: 40
Actual Study Start Date: June 20, 2017
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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

Drug: CKD-381
Test drug: CKD-381
Other Name: Esomeprazole 20mg+Sodum bicarbonate 800mg
Drug: Nexium
Reference drug: Nexium
Other Name: Esomeprazole magnesium trihydrate 22.3mg
Experimental: 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

Drug: CKD-381
Test drug: CKD-381
Other Name: Esomeprazole 20mg+Sodum bicarbonate 800mg
Drug: Nexium
Reference drug: Nexium
Other Name: Esomeprazole magnesium trihydrate 22.3mg

Detailed Description:
A randomized, open-label, multiple-dose, and crossover study to compare pharmacokinetics, pharmacodynamics and safety of CKD-381 and D027 in healthy subjects
  Eligibility

Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between 19 aged and 55 aged in healthy adult
  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:

  1. Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03211143

Contacts
Contact: Choon Ok Kim, MD +82-2228-0455 Delivery98@yuhs.ac

Locations
Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: ChoonOk Kim, MD    +82-2228-0455    Delivery98@yuhs.ac   
Principal Investigator: ChoonOk Kim, MD         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
Principal Investigator: Choon Ok Kim, MD Clinical Trials center, Yonsei Univ. Health system
  More Information

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03211143     History of Changes
Other Study ID Numbers: 173HPS16024
Study First Received: July 5, 2017
Last Updated: July 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chong Kun Dang Pharmaceutical:
GERD
CKD-381
Nexium
Bioeqivalence

Additional relevant MeSH terms:
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 11, 2017