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

NCT03211143 | Completed Phase 1

• 1 other identifier: 173HPS16024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

GERD

Keywords

GERD; CKD-381; Nexium; Bioequivalence

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

A

EXPERIMENTAL

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

B

EXPERIMENTAL

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

CKD-381 DRUG

Test drug: CKD-381

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

A; B

Nexium DRUG

Reference drug: Nexium

Also known as: Esomeprazole magnesium trihydrate 22.3mg

A; B

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between 19 aged and 55 aged in healthy adult
• Body weight more than 55kg in male, 50kg in female
• Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
• 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
• 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
• 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.

You may not qualify if:

• 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.
• Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
• Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
• Have a history of fructose intolerance, glucose-galactose malabsorbtion or sucrase isomaltase deficiency
• 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.
• Have a history of drug abuse
• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 31564831 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Choon Ok Kim, MD

  Clinical Trials center, Yonsei Univ. Health system

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: July 7, 2017
• Study Start: June 20, 2017
• Primary Completion: August 28, 2017
• Study Completion: August 28, 2017
• Last Updated: November 21, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)