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

NCT ID: NCT04304547

Last Updated: 2020-08-13

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

2020-02-04

Study Completion Date

2020-04-02

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, D097 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

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence A

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Group Type ACTIVE_COMPARATOR

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Intervention Type DRUG

Subject of sequence A takes IP in the following order:

1. Each tablet of CKD-828 and D097 and D337 be taken at once
2. CKD-348 T1 1 tablet
3. CKD-348 T2 1 tabet

Sequence B

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Group Type ACTIVE_COMPARATOR

CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Intervention Type DRUG

Subject of sequence B takes IP in the following order:

1. CKD-348 T1 1 tablet
2. CKD-348 T2 1 tablet
3. Each tablet of CKD-828 and D097 and D337 be taken at once

Sequence C

CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Group Type ACTIVE_COMPARATOR

CKD-348 T2, CKD-348 T1, CKD-828, D097, D337

Intervention Type DRUG

Subject of sequence C takes IP in the following order:

1. CKD-348 T2 1 tablet
2. Each tablet of CKD-828 and D097 and D337 be taken at once
3. CKD-348 T1 1 tablet

Interventions

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CKD-828, D097, D337, CKD-348 T1, CKD-348 T2

Subject of sequence A takes IP in the following order:

1. Each tablet of CKD-828 and D097 and D337 be taken at once
2. CKD-348 T1 1 tablet
3. CKD-348 T2 1 tabet

Intervention Type DRUG

CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,

Subject of sequence B takes IP in the following order:

1. CKD-348 T1 1 tablet
2. CKD-348 T2 1 tablet
3. Each tablet of CKD-828 and D097 and D337 be taken at once

Intervention Type DRUG

CKD-348 T2, CKD-348 T1, CKD-828, D097, D337

Subject of sequence C takes IP in the following order:

1. CKD-348 T2 1 tablet
2. Each tablet of CKD-828 and D097 and D337 be taken at once
3. CKD-348 T1 1 tablet

Intervention Type DRUG

Other Intervention Names

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Sequence A Sequence B Sequence C

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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Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Yong Chung

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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A86_04BE1913P

Identifier Type: -

Identifier Source: org_study_id

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