NCT03558425

Brief Summary

A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

June 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 14, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
Last Updated

October 12, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

June 1, 2018

Last Update Submit

October 11, 2018

Conditions

GERD

Keywords

CKD-381D026

Outcome Measures

Primary Outcomes (2)

  • AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)

    Evaluation PK for Esomeprazole after multiple dose

    0~24h

  • Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose

    Evaluation PD for ambulatory 24hr pH monitor

    Baseline versus Multiple dose during 7 days

Study Arms (2)

TR group

EXPERIMENTAL

Period 1: Test drug(CKD-381) Period 2: Reference drug(D026)

Drug: D026

RT group

EXPERIMENTAL

Period 1: Reference drug(D026) Period 2: Test drug(CKD-381)

Drug: CKD-381

Interventions

CKD-381DRUG

1 tablet administered before the breakfast during 7 days

RT group
D026DRUG

1 tablet administered before the breakfast during 7 days

TR group

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between 19 aged and 50 aged in healthy male adult
  • Body weight more than 55kg
  • Body Mass Index more than 18.5 and under 25

You may not qualify if:

  • Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can effect drug absorption or surgery.
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Nat'l University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Kyung Sang Yu, M.D., Ph.D.

    Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l University College of Medicine and Hospital

    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

June 1, 2018

First Posted

June 15, 2018

Study Start

June 27, 2018

Primary Completion

September 14, 2018

Study Completion

September 14, 2018

Last Updated

October 12, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)