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A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects

NCT ID: NCT05108038

Last Updated: 2021-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2022-02-28

Brief Summary

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to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Detailed Description

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A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Conditions

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GERD

Keywords

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CKD-382 D860 D027

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Period 1: CKD-382 Period 2: D860 Period 3: D027

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

B

Period 1: CKD-382 Period 2: D027 Period 3: D860

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

C

Period 1: D860 Period 2: D027 Period 3: CKD-382

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

D

Period 1: D860 Period 2: CKD-382 Period 3: D027

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

E

Period 1: D027 Period 2: D860 Period 3: CKD-382

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

F

Period 1: D027 Period 2: CKD-382 Period 3: D860

Group Type EXPERIMENTAL

CKD-382, D860, D027

Intervention Type DRUG

QD, PO for 7days

Interventions

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CKD-382, D860, D027

QD, PO for 7days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Between 19 aged and 50 aged in healthy adult
* Body weight more than 50kg
* BMI more than 18.0 and under 27.0
* Who has negative result on Helicobacter Pylori antibody test

Exclusion Criteria

* 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(including surgery) that can effect drug absorption
* Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chungbuk Ntional University Hospital

Cheongju-si, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Minkyu Park, Ph.D

Role: CONTACT

Phone: 043-269-8708

Email: [email protected]

Facility Contacts

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Minkyu Park, Ph.D

Role: primary

Other Identifiers

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A105_02PK2115

Identifier Type: -

Identifier Source: org_study_id