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

A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D027 in Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: CKD-381; Drug: Nexium

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

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Esomeprazole 20mg+Sodum bicarbonate 800mg; Drug: Nexium; Reference drug: Nexium; Other Names: 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 Names: Esomeprazole 20mg+Sodum bicarbonate 800mg; Drug: Nexium; Reference drug: Nexium; Other Names: Esomeprazole magnesium trihydrate 22.3mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics(Area under the plasma drug concentration-time curve within a dosing interval(AUCτ))	Evaluating PK of Esomeprazole after Multiple dose	0h~12 h
Pharmacodynamics(Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose)	Evaluating PD for ambulatory 24hr pH monitor	Baseline versus Multiple dose during 7days

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Choon Ok Kim, MD, Clinical Trials center, Yonsei Univ. Health system

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): August 28, 2017
• Study Completion (Actual): August 28, 2017

Study Registration Dates

• First Submitted: July 5, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: GERD; Bioequivalence; Nexium; CKD-381
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: 173HPS16024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No