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CompletedNCT03211143Updated Nov 21, 2017

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

A Phase 1 interventional study of CKD-381 and Nexium in GERD, sponsored by Chong Kun Dang Pharmaceutical. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-21.

Sponsored by Chong Kun Dang Pharmaceutical · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
19 Years to 50 Years
Sex
All
01

Study summary

A Study to compare Pharmacokinetics, Pharmacodynamics and safety of CKD-381 and D027 in healty subjects

Read the 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

02

Conditions studied

  • GERD

Keywords

  • GERD
  • CKD-381
  • Nexium
  • Bioequivalence
03

In context

Lead sponsor

Chong Kun Dang Pharmaceutical is the lead sponsor of 293 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
41 participants (actual)

Study arms

  • 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 · Drug: Nexium

  • 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 · Drug: Nexium

Interventions

  • DrugCKD-381

    Test drug: CKD-381

    Also known as: Esomeprazole 20mg+Sodum bicarbonate 800mg

  • DrugNexium

    Reference drug: Nexium

    Also known as: Esomeprazole magnesium trihydrate 22.3mg

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ))

    Evaluating PK of Esomeprazole after Multiple dose

    Time frame: 0h~12 h

  2. Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose)

    Evaluating PD for ambulatory 24hr pH monitor

    Time frame: Baseline versus Multiple dose during 7days

07

Study locations

1 site
  • Severance Hospital
    Seoul, Korea, Republic of
08

References and documents

Publications

  • 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. PubMed 31564831 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03211143
Lead sponsor
Chong Kun Dang Pharmaceutical
Responsible party
Sponsor
First posted
Jul 7, 2017
Start date
Jun 20, 2017
Primary completion
Aug 28, 2017
Completion
Aug 28, 2017
Last update
Nov 21, 2017

Study contacts

Choon Ok Kim, MD
principal investigator · Clinical Trials center, Yonsei Univ. Health system

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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