Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-348 in Healthy Volunteers

NCT ID: NCT04272502

Last Updated: 2020-02-17

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-04

Study Completion Date

2019-08-26

Brief Summary

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Phase I clinical trial to compare the pharmacokinetics and safety of CKD-348 with co-administration of CKD-828, D326 and D337 in healthy adult volunteers

Detailed Description

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Conditions

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Healthy

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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Sequence A

CKD-828, D326, D337, CKD-F1, CKD-F2

Group Type EXPERIMENTAL

CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Intervention Type DRUG

Each arm has a different order for taking IP

Sequence B

CKD-828, D326, D337, CKD-F1, CKD-F2

Group Type EXPERIMENTAL

CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Intervention Type DRUG

Each arm has a different order for taking IP

Sequence C

CKD-828, D326, D337, CKD-F1, CKD-F2

Group Type EXPERIMENTAL

CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Intervention Type DRUG

Each arm has a different order for taking IP

Interventions

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CKD-348 F1, CKD-348 F2, CKD-828, D326, D337

Each arm has a different order for taking IP

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. 19 ≤ age ≤ 45
2. Health Volunteers
3. Subject who agreeds to participate in this clinical trial voluntarily

Exclusion Criteria

1\. Subject who cannot participate in a clinical trial based on the PI's judgment
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Bundang Hospital

Gyeonggi-do, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A86_02BE1902P

Identifier Type: -

Identifier Source: org_study_id

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